Novartis (NYSE: NVS) suffered a setback when the Committee for Medicinal Products for Human Use (CHMP) maintained a negative opinion on pipeline candidate RLX030 (serelaxin).
Novartis is evaluating RLX030 for the treatment of acute heart failure (AHF).
We note that Novartis had requested for a re-examination after the CHMP issued a negative opinion in Jan 2014.
The CHMP indicated that Novartis will be required to provide additional data to get the candidate approved in the EU.
Hence, Novartis now plans to resubmit additional data from its ongoing phase III trial, RELAX-AHF-2, on RLX030 for approval.
Earlier in the month, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (NYSE: CRL) to Novartis' Biologics License Application (BLA) for RLX030.
The FDA requires further evidence on the efficacy of RLX030 to approve the candidate in the U.S.
The BLA submitted to the FDA included phase II and III efficacy and safety data from the clinical development program on RLX030, including the data from the phase III RELAX-AHF study.
Novartis will now work to expedite its clinical trial program and provide additional data to the FDA also.
We are disappointed by the setback. We expect investor focus to remain on further updates on revised filing in the U.S. and EU.
Nevertheless, Novartis has another candidate, LCZ696, in its pipeline which is being evaluated for chronic heart failure.
On a positive note, the CHMP issued a positive opinion to Novartis' Simbrinza. Novartis is seeking EU approval for Simbrinza to decrease elevated intraocular pressure (IOP) in adult patients suffering from open-angle glaucoma or ocular hypertension, for whom monotherapy provides insufficient IOP reduction. Simbrinza is already approved in the U.S.
Novartis currently carries a Zacks Rank #3 (Hold). Currently, stocks like Allergan (NYSE: AGN), Gilead Sciences (NASDAQ: GILD) and Astellas Pharma, Inc. (ALPMY) look attractive in the healthcare sector. While Allergan and Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Astellas Pharma is a Rank #2 (Buy) stock.
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