Pfizer and Sanofi Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Pfizer and Sanofi.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday April 26, 2017 to Tuesday May 2, 2017.
Pfizer’s Lung Cancer Drug Gains Breakthrough Therapy Status
Pfizer has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for lorlatinib, its investigational drug for treating anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer, previously treated with one or more ALK inhibitors.
Lorlatinib is an investigational next-generation ALK/ROS1 tyrosine kinase inhibitor that has been shown to be active in preclinical lung cancer models. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier. Lorlatinib has not received regulatory approval for any indication.
FDA Accepts Sanofi’s Resubmission of Arthritis Drug
The US Food and Drug Administration has accepted the resubmission of the biologics license application (BLA) filed by Sanofi and its partner, Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, for Kevzara (sarilumab), an investigational biologic for treating moderately to severely active rheumatoid arthritis (RA), as a Class I response with a two-month review timeline. Per the Prescription Drug User Fee Act (PDUFA), the new target action date is May 22, 2017. If approved, the drug would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.
In October 2016, the companies received a Complete Response Letter (CRL) from the FDA related to certain deficiencies identified during a routine GMP inspection of the Sanofi Le Trait facility in the Haute-Normandie region in France where sarilumab is filled and finished. At the time, Sanofi submitted a corrective action plan to the FDA and has since implemented the corrective actions specified in that plan. The CRL did not identify any concerns relating to the safety or efficacy of sarilumab.
In late April 2017, the companies received a positive opinion for Kevzara from the European Medicine Agency’s Committee for Medicinal Products for Human Use, and the European Commission is expected to make a final decision on the marketing authorization application for Kevzara in the European Union in the coming months. Kevzara is approved in Canada for treating moderately to severely active RA in patients who have had an inadequate response or intolerance to one or more biologic or non-biologic disease modifying antirheumatic drugs. The companies are also seeking approvals in a number of other countries globally.