Regulatory Briefs: Novartis And GSK See Approvals, TMC And Acorda Don’t
In a busy week for FDA drug approval actions, agency clears Novartis’ “breakthrough therapy” ceritinib for lung cancer and GlaxoSmithKline’s stand-alone COPD treatment umeclidinium but hands “complete response” letters to The Medicines Co. and Acorda Therapeutics.
You may also be interested in...
FDA grants accelerated approval to ceritinib following a four-month review. The ALK inhibitor is indicated for non-small cell lung cancer patients who have progressed on or are intolerant of Pfizer’s Xalkori.
The Medicines Co.’s anti-clotting drug had one relatively positive study, but two failed ones, and that produced two lopsided “no” votes by the Cardiovascular and Renal Drugs Advisory Committee.
FDA approved GSK’s Anoro Ellipta as the first LABA/LAMA combination product in the U.S. for the maintenance treatment of COPD Dec. 18, positioning GSK to launch a second respiratory product months after launching Breo Ellipta.