) suffered a setback when the U.S. Food and Drug Administration
(FDA) issued a Complete Response Letter (CRL) to its Biologics
License Application (BLA) for pipeline candidate RLX030
Novartis was seeking approval of RLX030 for the treatment of
acute heart failure (AHF). 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. A second phase III study,
RELAX-AHF (n=6300) on RLX030 is currently underway to support the
efficacy of the candidate.
We remind investors that the Cardiovascular and Renal Drugs
Advisory Committee (CRDAC) of the FDA voted against the approval of
the candidate RLX030 in Mar 2014. The FDA had earlier granted
Breakthrough Therapy (BT) designation status to RLX030 in Jun
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) also issued a negative opinion on
RLX030 in Jan 2014.
We are disappointed by the setback of RLX030. We expect investor
focus to remain on further updates on revised filing in the U.S.
Nevertheless, Novartis has another candidate, LCZ696, in its
pipeline which is being evaluated for chronic heart failure.
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.
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