Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. These updates
provide information on experimental drugs and at times give an
insight into the commercial potential of the candidate once it is
successfully developed and commercialized.
) suffered a setback when the U.S. Food and Drug Administration
(FDA) and Cardiovascular and Renal Drugs Advisory Committee
(CRDAC) voted against the approval of the candidate RLX030
(serelaxin) for the treatment of acute heart failure.
The news was diasppointing as Novartis had presented
encouraging efficacy and safety data from a phase II and phase
III study wherein it was observed that RLX030 improved the
symptoms of acute heart failure (AHF).
We note that the FDA will consider the recommendation of the
Advisory Committee for its review of the Biologics License
Application (BLA) for RLX030 but not necessarily follow it.
We note that the FDA granted Breakthrough Therapy (BT)
designation status to RLX030 in Jun 2013.
Nevertheless, Novartis plans to work closely with the FDA on
the future development of RLX030.
Meanwhile, a global phase III study is underway on RLX030 and
results are expected in 2016.
Last week, Novartis received positive news when the FDA
approved Xolair for an additional indication. Xolair is now
approved in the U.S. for the treatment of chronic idiopathic
urticaria (CIU), in adults and adolescents (12 years and above)
with inadequate response to H1-antihistamine treatment.
CIU is known as chronic spontaneous urticaria (CSU) outside
the U.S. Xolair is already approved in the U.S. for
moderate-to-severe persistent allergic asthma. Earlier this
month, Xolair won approval for the CSU indication (as a
combination therapy) in Europe.
In addition, Novartis reported results from two pivotal phase
III studies, FEATURE and JUNCTURE, which evaluated psoriasis
candidate, secukinumab (AIN457) in clearing patients' skin.
Novartis currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
). All three carry a Zacks Rank #1 (Strong Buy).
NOVARTIS AG-ADR (NVS): Free Stock Analysis
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