FDA Decision Analysis: SCIO
The
FDA advisory committee for cardiovascular and renal drugs met Friday,
May 25, and unanimously approved the use of Scios’
(
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PowerRating) new drug Natrecor
for the treatment of congestive heart failure. Trading in Scios was halted all
day Friday pending the FDA’s advisory panel decision. Over the last six months
the company’s stock price as increased nicely in anticipation of this decision.
Congestive heart failure (CHF) is a common disease in the over-65 crowd,
affecting up to 5 million people in the US. As the population ages over the next
10-20 years, this disease should become more prevalent, expanding the market
potential for any new treatment. The disease affects the intrinsic ability of
the heart muscle to adequately pump blood to the rest of the body. Part of the
current treatment today involves drugs that aim to reduce the stress on the
heart by decreasing the blood volume to the heart during acute periods of
flare-up.
Natrecor (generically known as
nesiritide) is a genetically created version of a natural hormone secreted by
the body. This hormone works by dilating the blood vessels returning blood to
the heart. By doing this, blood volume to heart is reduced and stress is lessened to a failing heart.
Natrecor was originally approved by the FDA advisory committee two years ago (at that time the vote was
a close 5 to 3). However, several months later, the full FDA rejected Scio’s
application for Natrecor to treat CHF and had several reservations about its
safety compared to existing treatments. Normally, the full FDA goes along with
its advisory committee recommendations but two years ago, this was not the case.
 This time I do not see the full FDA rejecting Natrecor as a treatment for
congestive heart failure because Scios adequately addressed all the committee’s
concerns at the Friday meeting. Over the next several years, I expect Natrecor
to make some inroads into the potential $300 million market for the treatment of
CHF.
In addition to Natrecor, Scios is also developing a new drug to treat rhematoid arthritis and hopes to take a bite out of this multibillion-dollar market in the next several years.