By Jennifer Corbett Dooren
WASHINGTON--The U.S. Food and Drug Administration has approved
the most new drugs in eight years--partly reflecting improvements
by the pharmaceutical industry in moving experimental drugs out of
company pipelines.
Through the end of November the agency approved 31 new types of
drugs, for diseases like cancer, multiple sclerosis, rheumatoid
arthritis and HIV, in addition to the first weight-loss drug
approved in more than a decade.
The agency still has the rest of the month to add to its total,
and has already approved the most new medicines since 2004, when it
granted 36 approvals to new drugs. Still, at least one highly
anticipated approval expected this year--a new Biogen Idec Inc.
(BIIB) MS drug--has been delayed. In October the company announced
the FDA needed three more months to review the application for the
product, dubbed BG-12. Investors had been hoping for BG-12's
approval this month so it could start to compete with another MS
drug, Sanofi SA's (SNY, SNY.FR) Aubagio, which was given the green
light in September.
The FDA considers new medicines to be those made from new
chemicals or proteins that are designed to treat illnesses in
different ways than existing treatments. For example, Vivus Inc's
(VVUS) July approval of its weight-loss drug Qsymia isn't included
in the new-drug category because it's a combination of two existing
drug ingredients. But the other weight-loss drug approved this
year--Arena Pharmaceuticals Inc. (ARNA) Belviq--counts because it
contains a new ingredient.
The agency also approves dozens of existing drugs each year for
new uses along with approving generic version of brand name
products after they lose patent protection.
The agency detailed many of its new 2012 approvals in a separate
report released Wednesday, which tallied numbers by the
government's fiscal year, which starts Oct. 1. The report took a
slightly broader approach to what's considered a new medicine than
has traditionally been done by FDA's drug staff. For example, it
counted a childhood vaccine that combined components of separate
vaccines for meningitis and other bacterial infections. Still the
report's figures were mostly similar to the agency's traditional
tracking methods and showed 35 new approvals in fiscal year 2012
compared to the same number in fiscal 2011. For calendar year 2011,
FDA figures showed 30 new drug approvals compared to 21 in 2010 and
26 in 2009.
The agency said the number of new drugs from small biotech firms
was "notable," and included things like Vertex Pharmaceuticals
Inc.'s (VRTX) treatment for a group of cystic fibrosis patients
with a specific gene mutation and Xtandi, a prostate cancer drug
developed by Medivation Inc. (MDVN). Big pharmaceuticals companies
like Bayer AG (BAYRY), Roche Holding AG (RHHBY, ROG.VX), Pfizer
Inc. (PFE) and Sanofi also had cancer drugs approved this year.
Agency officials have said drug-approval totals often reflect
the number of new-drug applications filed by drug companies in the
prior year or early in the calendar year. However, the agency only
makes its approvals public and is prohibited by law from discussing
products it delays or rejects. A standard drug review usually takes
10 months, while a medicine thought to be an advance over an
existing treatment can be deemed a priority and given a six-month
review.
Write to Jennifer Corbett Dooren at
jennifer.corbett@dowjones.com
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