Biogen, BMS, Pfizer, and Sanofi Lead Pipeline News
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Biogen, BMS, Pfizer, and Sanofi.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday April 19, 2017 to Tuesday April 25, 2017.
Biogen Gains Positive EMA Opinion on Spinal Muscular Atrophy Drug
Biogen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending the granting of a marketing authorization for Spinraza (nusinersen) to treat spinal muscular atrophy (SMA). The CHMP reviewed Spinraza under an accelerated assessment program.
The CHMP positive opinion is now referred to the European Commission (EC), which grants the marketing authorization for centrally authorized medicines in the European Union. The CHMP recommended an indication for treating 5q SMA, the most common form of the disease. A decision from the EC is expected in the next few months.
Spinraza, projected by some analysts to be a blockbuster drug, was approved in the US by the US Food and Drug Administration in December 2016. Biogen partnered with Ionis Pharmaceuticals, a Carlsbad, California-based pharmaceutical company, in 2012 to develop Spinraza in a deal worth $299 million.
EMA Positive on New Indication for BMS’ Cancer Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended for approval Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) in a new indication to treat locally advanced unresectable or metastatic urothelial carcinoma. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Opdivo is a blockbuster drug for BMS with 2016 sales of $3.77 billion.
Opdivo is already approved by the EC for six indications in four distinct tumor types. Opdivo first received regulatory approval in July 2014 and is currently approved in more than 60 countries, including the US, EU, and Japan. In the US, Opdivo is indicated for treating unresectable or metastatic melanoma as a single agent, unresectable or metastatic melanoma in combination with Yervoy (ipilimumab), metastatic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic urothelial carcinoma.
Source: Bristol-Myers Squibb
EMA Positive on Pfizer’s Leukemia Drug
Pfizer has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending approval of Besponsa (inotuzumab ozogamicin), an investigational antibody-drug conjugate, in the European Union (EU) as monotherapy to treat relapsed or refractory CD22-positive B-cell precursor Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) and Philadelphia chromosome positive (Ph+) ALL. The CHMP’s opinion will now be reviewed by the European Commission.
In addition to the EMA filing, Pfizer also filed a biologics license application for Besponsa, with the US Food and Drug Administration (FDA) for treating relapsed or refractory B-cell precursor ALL, which has been accepted for filing and granted priority review. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2017. Besponsa also received breakthrough therapy designation from the FDA in October 2015 for ALL.
Sanofi Gains Positive EMA Opinion on Arthritis Drug
Sanofi and partner, Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency for the marketing authorization of Kevzara (sarilumab), recommending its approval for treating moderately to severely active rheumatoid arthritis (RA). Kevzara is an investigational human monoclonal antibody directed against the interleukin-6 (IL-6) receptor.
The CHMP recommended the use of Kevzara in combination with methotrexate (MTX) for treating moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. The European Commission is expected to make a final decision on the marketing authorization application for Kevzara in the coming months.
In Canada, Kevzara is approved for treating moderately to severely active RA in adults who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs. Sarilumab is currently under review in the US, and the companies are also seeking approvals in a number of other countries globally.