Nov 6 FDA

NOTIZIA

FDA approves Zulresso of Sage

Sage Therapeutics, a clinical-stage biopharmaceutical company committed to the treatment of central nervous system (CNS) disorders, receives U.S. approval for its postpartum depression (PPD) drug Zulresso from the Food and Drug Administration when received 17-1 in favour of the therapy’s risk-benefit profile. The supporting vote was largely expected but came with a proviso: committee experts agreed that the injectable drug would be best used through a Risk Evaluation and Mitigation Strategy (REMS) program. Zulresso would become the first drug specifically approved by the FDA for the treatment of PPD.

Pfizer receives cancer drug approval for Lorbrena

The Food and Drug Administration has given a nod to Pfizer’s Lorbrena as a second-line therapy for patients with ALK-mutated non-small cell lung cancer (NSCLC). Lorbrena will come to market under an accelerated approval based on results from a Phase 1/2 study, which showed treatment with the drug led to a 48% overall response rate in patients previously treated with one or more other therapies. A tyrosine kinase inhibitor (TKI), Lorbrena helps to support lung cancer franchise of Pfizer.

Novartis relinquishes biosimilar Rituxan in US

Novartis’ Sandoz unit apprised of not pursuing U.S. approval of a biosimilar version of Roche’s cancer drug Rituxan, after receiving a request from the Food and Drug Administration for more data. The company informs that it cannot fulfil the FDA request before the patient and marketplace needs in the U.S. will be satisfied for biosimilar versions of the treatment.

Less chances of Alkermes for receiving approval from FDA

Alkermes chances of receiving U.S. approval for an experimental depression drug look less after an advisory panel to the Food and Drug Administration concluded clinical data presented by the company was not enough to receive a regulatory OK. Committee experts voted 21-2 against recommending approval, leading to concerns raised by FDA staff in briefing document. Alkermes’ pitch for its drug, called ALKS-5461, already faced complications. Only one of three Phase 3 trials conducted by the company received a nod, while an unusual clinical trial design used in two of the studies had met issues from the FDA.

 

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