) 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
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 (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,
Astellas Pharma, Inc
) 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.
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
ALLERGAN INC (AGN): Free Stock Analysis Report
ASTELLAS PHARMA (ALPMY): Get Free Report
GILEAD SCIENCES (GILD): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
To read this article on Zacks.com click here.