Lilly’s Baricitinib is Recommended by CHMP for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA)

Dec. 16, 2016

Eli Lilly and Company and Incyte Corporation have announced that the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued a positive opinion recommending the approval of baricitinib – which if approved, would be marketed as Olumiant®. Baricitinib is recommended to be used for treating moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate. This recommendation from CHMP is expected to be followed by the approval from the European Commission, who will make the decision on marketing authorization.

Andrew Hotchkiss, president of Lilly’s European and Canadian operations, said: “Rheumatoid arthritis is a debilitating disease and can have a devastating impact on a person’s quality of life. There is no cure for rheumatoid arthritis and although improvements have been seen in the long-term outcomes for patients, not all people reach low disease activity or remission. Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU. It is an important milestone for people living with rheumatoid arthritis and Lilly is committed to improving outcomes for people living with this chronic condition.”

“The positive opinion for baricitinib paves the way for adults with rheumatoid arthritis to be offered a new treatment option. Incyte is proud to have partnered with Lilly on the research and development of this promising medicine, and we are pleased that the CHMP positive opinion brings us one step closer to providing baricitinib to the many people living with this chronic condition,” said Steven Stein, M.D., chief medical officer, Incyte Corporation.

Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis

November 25 2016

Janssen-Cilag International NV has announced about the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) that seeks approval of guselkumab for treating adults with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody targeting the protein interleukin (IL)-23, which plays an important role in developing immune-mediated inflammatory diseases. Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells. This is often characterized by raised, scaly, inflamed, red lesions, or plaques, that can cause itching, discomfort and pain. According to a recent estimate, 14 million people in Europe have psoriasis, which can range from mild to severe and disabling, and can often impair quality of life significantly.

Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC, said: “We are committed to the discovery and development of innovative therapies to address the continued unmet medical needs of people living with psoriasis. We look forward to working with the EMA during the agency’s review of the application as we seek approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis in the European Union.”

EMA Validates the Marketing Authorization Application for Avelumab for Treating Metastatic Merkel Cell Carcinoma

 

October 31, 2016

KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC). It is an aggressive and rare skin cancer, which impacts approximately 2,500 Europeans a year. If approved, avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, could be the first approved treatment in the EU indicated for metastatic MCC. Metastatic MCC patients face a very poor prognosis, with less than 20 percent surviving beyond five years.

Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono, said: “While early-stage Merkel cell carcinoma can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited. We are pleased that the EMA is initiating its review of avelumab, as this means we are one step closer to bringing a much-needed new treatment option to European patients.”

“This is the first of what we hope will be many regulatory milestones for avelumab. We are committed to evaluating avelumab in a number of hard-to-treat cancers, and we believe it may have potential to be an important treatment option for patients with metastatic Merkel cell carcinoma,” said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development.

Top Pharma News – September and October, 2016

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Bristol-Myers Squibb’s ORENCIA® (abatacept) is Approved by European Commission for the Treatment of Adult Patients with Rheumatoid Arthritis

September 6, 2016

Bristol-Myers Squibb Company has announced that the European Commission has approved ORENCIA ® (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, combined with methotrexate (MTX), for treating highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. Through this approval, ORENCIA has turned out as the first biologic therapy with an indication in the European Union (EU) specifically applicable to the treatment of MTX-naive RA patients with highly active and progressive disease. This approval permits the expanded marketing of ORENCIA in all 28 Member States of the EU.

FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

September 7, 2016

Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for KEYTRUDA^® (pembrolizumab) for Priority Review.  KEYTRUDA® is Merck’s anti-PD-1 therapy that is used as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). In addition, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA^®.

Janssen Submits Marketing Authorisation Application to European Medicines Agency for Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

September 12, 2016

Janssen-Cilag International NV (Janssen) has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA), which seeks approval for a new once-daily darunavir-based single tablet regimen (STR). This tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC) if approved, indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg).

Janssen submits application to European Union seeking approval of sirukumab for rheumatoid arthritis

September 12, 2016

Janssen-Cilag International NV (Janssen) has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for treating adult patients with moderately to severely active rheumatoid arthritis (RA). Approximately 6.2 million Europeans are affected by RA, which is a chronic, systemic inflammatory condition. Sirukumab is a human monoclonal IgG1 kappa antibody targeting the cytokine IL-6, a naturally occurring protein that is believed to play a key role in autoimmune conditions like RA.

Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Metformin and Sitagliptin for the Treatment of Type 2 Diabetes

September 15, 2016

Merck, in partnership with Pfizer Inc., has announced that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 15 mg and 5 mg daily doses of ertugliflozin revealed meaningfully greater reductions in A1C of 0.69 percent and 0.76 percent, respectively, in comparison with placebo (p<0.001, for both comparisons), when added to patients on a background of stable metformin (≥1500 mg/day) and sitagliptin (100 mg/day). For the first time, these study results were presented during an oral session at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.

Phase III combination trial of Bydureon and Forxiga shows significant benefits in patients with type-2 diabetes

September 16, 2016

Positive results from the Phase III DURATION-8 trial confirmed that Bydureon (exenatide extended-release formulation) 2mg once weekly, combining with Forxiga (dapagliflozin) 10mg once daily significantly reduced blood sugar as measured by HbA1c, versus the individual medicines alone in patients with type-2 diabetes ineffectively controlled on metformin. The results were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany, and simultaneously published in the journal ‘The Lancet Diabetes & Endocrinology’.

Pfizer Gets Positive CHMP Opinion for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for The Treatment of HR+/HER2- Metastatic Breast Cancer in Europe

September 16, 2016

Pfizer Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that IBRANCE® (palbociclib) be granted marketing authorization in the European Union (EU) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. This positive opinion from CHMP is for IBRANCE to be used in combination with fulvestrant in women who have received prior endocrine therapy, as well as in combination with an aromatase inhibitor. European Commission (EC) will now review The CHMP’s opinion.

U.S. FDA Accepts Biologics License Application for Romosozumab, Amgen and UCB Announce

September 26, 2016

Amgen and UCB have announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab. It is an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and hindering the activity of the protein sclerostin, naturally occurring in the bone, thereby reducing bone resorption and increasing bone formation.

Amgen Announces Top-Line Results from Phase 3 KYPROLIS® (Carfilzomib) CLARION Study in Patients with Newly Diagnosed Multiple Myeloma

September 27, 2016

Amgen has announced top-line results of the Phase 3 CLARION trial evaluating an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were not eligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS). The observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 – 1.64) while the data for overall survival, a secondary endpoint, are not yet mature. Neither result was statistically significant. These data will be submitted to a future medical conference and for publication.

Two Cardiovascular Collaborations Announced by Amgen and Arrowhead Pharmaceuticals

September 29, 2016

Amgen and Arrowhead Pharmaceuticals Inc. have announced two license and collaboration agreements to develop and commercialize RNA interference (RNAi) therapies for cardiovascular disease. Under the first agreement, Amgen receives a worldwide, exclusive license to Arrowhead’s novel, RNAi ARC-LPA program. The RNAi molecules are designed to decrease elevated lipoprotein, which is a genetically validated, independent risk factor for atherosclerotic cardiovascular disease. As per the second agreement, Amgen receives an option to a worldwide, exclusive license for a RNAi therapy for an undisclosed genetically validated cardiovascular target. Amgen will be wholly responsible for clinical development and commercialization in both agreements.

Treatment outcome data from The Prostate Cancer Registry presented for the first time at the 2016 ESMO Congress

October 10, 2016

Janssen-Cilag International NV has presented the first reported primary treatment outcome data from The Prostate Cancer Registry at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark. The Prostate Cancer Registry is the first and largest prospective study of men with metastatic castration-resistant prostate cancer (mCRPC) in Europe. The preliminary data suggest that chemotherapy-naïve patients benefit more from treatment than post-chemotherapy patients. Furthermore, patients have a higher prostate-specific antigen (PSA) response when treated with androgen receptor-targeted agents than with taxanes, after first line docetaxel treatment.

Pfizer Presented New Data on XELJANZ® for Ulcerative Colitis at UEG Week 2016

October 15, 2016

Pfizer Inc. announced that three abstracts for XELJANZ® (tofacitinib citrate), being investigated in moderate to severe ulcerative colitis (UC), were presented at the United European Gastroenterology Week (UEG Week 2016), October 15-19 in Vienna, Austria. The tofacitinib presentations highlighted new research results from the Phase 3 Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Induction trials, including one oral presentation looking at the impact of prior treatment with tumor necrosis factor inhibitors (TNFi) on efficacy endpoints. Furthermore, two abstracts were accepted as poster presentations, highlighting results by endoscopic response, and onset of action, respectively.

 

Amgen Announces Positive Top-Line Results From XGEVA® (Denosumab) Phase 3 Trial for Patients with Multiple Myeloma

October 20, 2016

Amgen has announced that a Phase 3 study evaluating XGEVA® (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. XGEVA’s hazard ratio versus zoledronic acid for overall survival was 0.90 (95 percent CI, 0.70 – 1.16).

NICE Recommends Oral OTEZLA^® (Apremilast) for Adults with Chronic Plaque Psoriasis

October 20, 2016

Celgene has announced that adult patients in England and Wales with chronic plaque psoriasis will now have access to oral OTEZLA ® (apremilast) after a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE). The decision is the conclusion of a NICE Rapid Review. It ensures patients in England and Wales will join those in Scotland, who have been benefitting from access to OTEZLA since Scottish Medicines Consortium (SMC) recommended it in June 2015. It has been estimated that Psoriasis has affected around 960,000 adults in the UK, seriously impacting their daily lives.

Pfizer Gets Positive CHMP Opinion for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for The Treatment of HR+/HER2- Metastatic Breast Cancer in Europe

September 16, 2016

Pfizer Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that IBRANCE® (palbociclib) be granted marketing authorization in the European Union (EU) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. This positive opinion from CHMP is for IBRANCE to be used in combination with fulvestrant in women who have received prior endocrine therapy, as well as in combination with an aromatase inhibitor. European Commission (EC) will now review The CHMP’s opinion.

Mace Rothenberg, M.D., chief development officer, Pfizer Oncology, said: “Today’s opinion by the CHMP to recommend marketing authorization of IBRANCE in the EU is an important step toward expanding treatment options for women in Europe with HR+/HER2- metastatic breast cancer, and a step toward a potential new standard of care for this cancer. The opinion is supported by robust data with consistent results observed across three separate randomized trials in which the addition of IBRANCE to standard endocrine therapy resulted in significant prolongation of progression-free survival compared to endocrine therapy alone.”

“There have been only modest improvements in the prognosis of patients with metastatic breast cancer in Europe over the past three decades, underscoring the need for new treatment advances. We look forward to working with the EC as they conduct their review, with the goal of bringing this first-in-class medicine to appropriate patients across the EU,” said Andreas Penk, M.D., regional president, International Developed Markets, Pfizer Oncology.

Janssen Submits Marketing Authorisation Application to European Medicines Agency for Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

Sep 12, 2016

Janssen-Cilag International NV (Janssen) has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA), which seeks approval for a new once-daily darunavir-based single tablet regimen (STR). This tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC) if approved, indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg).

This new treatment would be the combination of the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg), tenofovir alafenamide (TAF 10 mg), and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) in one single tablet.

Lawrence M. Blatt, Ph.D., global therapeutic area head, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma, Inc., said: “Darunavir is an extensively used HIV protease inhibitor in the European Union. We are excited to take this important step in our efforts to offer simpler solutions for people living with HIV. Progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life. Eliminating the need for separate tablets will not only be convenient for people living with HIV but is likely to lead to improved treatment adherence.”

Janssen submits application to European Union seeking approval of sirukumab for rheumatoid arthritis

Sep 12, 2016

Janssen-Cilag International NV (Janssen) has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for treating adult patients with moderately to severely active rheumatoid arthritis (RA). Approximately 6.2 million Europeans are affected by RA, which is a chronic, systemic inflammatory condition. Sirukumab is a human monoclonal IgG1 kappa antibody targeting IL-6, a naturally occurring protein that is believed to play a key role in autoimmune conditions like RA.

Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC, said: “At Janssen, we are committed to continued innovation in the field of rheumatoid arthritis through new therapeutic options, like sirukumab, that address the medical needs of people living with moderately to severely active rheumatoid arthritis. We look forward to collaborating with the European health authorities with the goal of bringing sirukumab to patients living with rheumatoid arthritis who may benefit from this new biologic therapy.”

Pfizer Announces the Acceptance of European Medicines Agency for Reviewing Marketing Authorization Application for TRUMENBA®

May 20, 2016

Pfizer Inc. has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA® (Meningococcal Group B Vaccine) for review. This TRUMENBA has been developed for preventing invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older. This acceptance of this vaccine can be considered as the beginning of the regulatory review process in the EU.

“The EMA’s acceptance of TRUMENBA’s Marketing Authorization Application brings us one step closer to fighting this uncommon yet life-threatening disease worldwide, by helping to protect adolescents and adults who are at risk to contract meningococcal disease caused by serogroup B. At Pfizer we are committed to providing innovative vaccines that help people live the longest, healthiest lives possible,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc.

This MAA for TRUMENBA is based on a clinical trial dataset of nearly 20,800 adolescents and adults aged 10 years and older, which was studied at the global level. This dataset reveals the consistency of immune responses induced by vaccine to diverse disease-causing MnB strains and the well-studied tolerability and safety profile.