FDAnews Drug Daily Bulletin

Novartis Asks CHMP to Reconsider Negative Opinion of Heart Drug

Jan. 27, 2014
Novartis is preparing a revised filing package with new data on its acute heart failure drug RLX030, in the hopes that the Committee for Medicinal Products for Human Use of the European Medicines Agency will re-examine the candidate and grant it conditional approval.

CHMP issued a negative opinion for RLX030 (serelaxin), also known as Reasanz, Friday, questioning efficacy data from a Phase III study evaluating relief of shortness of breath in 1,161 acute heart failure patients at six, 12 and 24 hours, and then at five days. Novartis would have to gather additional information to confirm the drug’s effectiveness, the opinion states.

The company began enrolling patients in a second Phase III trial in September, with the goal of replicating results that showed that patients given Reasanz had a 37 percent decrease in mortality six months after an episode of acute heart failure compared to conventional treatment.

Revised filing information must be submitted within 15 days, and a new European opinion could come as early as the second quarter of this year. The FDA granted Reasanz breakthrough therapy designation in June; regulatory processes are underway in 16 other countries. — Lena Freund

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