Novartis drug rejected by EMA’s advisers; company to resubmit

Having been knocked back by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), Novartis has said it will make a revised submission for its drug for acute heart failure, serelaxin.

Novartis will submit for conditional marketing approval while a phase three study is ongoing. Meanwhile, the company will also submit data to the FDA on 13th February. The CHMP issued its negative opinion today, 24th January.

“It has become apparent through the review process and in accordance with advice we’ve received that the current evidence package may be more compatible with an application for conditional approval in the EU.

“We look forward to providing a revised package for review to the CHMP shortly.”

David Epstein, division head, Novartis Pharmaceuticals.

Novartis also received positive news from the CHMP, which issued a positive opinion on omalizumab (Xolair) as an add-on therapy for chronic spontaneous urticarial, a severe skin disease. The drug is already approved for use in asthma.

 

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Related news:

Novartis Heart Drug Suffers Setback (The Wall Street Journal).

Reference links:

Novartis to request re-examination of serelaxin (RLX030) in acute heart failure (AHF) for conditional marketing authorization in EU (Novartis press release).

Novartis reports positive opinion from CHMP for Xolair in severe form of skin disease CSU, a debilitating form of hives and chronic itch (Novartis press release).

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