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HEALTH INDUSTRY DECEMBER 31, 2010
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Drug Approvals Slipped in 2010Some Potential Blockbusters
Suffered Delay s Amid FDA's Tougher Safety Stance
By JENNIFER CORBETT DOOREN
WASHINGTONThe Food and Drug Administration approved about 21
drugs in 2010, a relatively modest figure
that shows the pharmaceutical industry hasn't yet escaped its
drought in recent years.
A few potential blockbusters won approval during the year, but
some of the most highly anticipated new products
got delayed into next year or beyond. That partly reflects a
tougher environment at the FDA, with regulators
stepping up their scrutiny of safety issues in drugs for
obesity, diabetes and other conditions.
According to monthly drug-approval reports on the FDA's website,
21 new
drugs were approved in 2010, down from 25 in 2009 and 24 in
2008, but
higher from a recent low of 18 in 2007.
The final approval figures, as well as the number of
applications received by
the agency in 2010, won't be available until next month. The
approval figures
don't include dozens of approvals granted for new formulations
or new uses
of existing drugs.
Although the 2010 figures are a bit lower than previous years,
FDA
spokeswoman Sandy Walsh said there's "no systemic change in how
the FDA
is approaching drug approvals."
The figures include several major biologic drugs, which are
created from
living cells and represent a growing portion of the
pharmaceutical market.
Amgen Inc. won approval for Prolia, a drug that is injected
twice yearly to
treat osteoporosis in postmenopausal women. Roche Holding
AG's
biotechnology unit, Genentech, won approval for Actemra, a drug
that's administered intravenously to treat
rheumatoid arthritis.
Boehringer Ingelheim GmbH received approval for Pradaxa, a new
type of blood-thinning drug to prevent strokes
in patients with irregular heart rhythms. The company got a head
start in a race among big drug makers to
replace warfarin, an anticoagulent approved in 1954 that is
still widely used.
AstraZeneca PLC suffered a setback in that race when the FDA
earlier this month asked for more information
about a study backing its application for the blood-thinning
drug Brilinta. The delay drove down AstraZeneca
shares more than 5%.
Patients with multiple sclerosis saw advances in treatment with
the October approval of Novartis AG's Gilenya, an
oral product. Multiple sclerosis has traditionally been treated
by injections or infusions. Earlier in the year, the
FDA also approvedAcorda Therapeutics Inc.'s drug Ampyra to
improve walking in MS patients.
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In August, the FDA approved ella, a longer-lasting emergency
contraceptive that's designed to block pregnancy
up to five days after sex. The product was developed by HRA
Pharma, a closely held company in Paris, and was
introduced in the U.S. earlier this month byWatson
Pharmaceuticals Inc.
In April, Dendreon Corp. won approval for its prostate cancer
therapy Provenge, which had previously been
rejected by the agency. Provenge is designed to use a patient's
own cells to stimulate the body's immune system to
fight the cancer and may be the first in a new class of
cancer-fighting drugs.
However, 2010 may be more notable for drugs that weren't
approved, as well as for drugs the agency restricted or
pulled off the market.
In addition to putting off a decision on Brilinta, the FDA also
rejected a long-acting version of diabetes drug
Byetta, sold byAmylin Pharmaceuticals Inc. and Eli Lilly &
Co., saying more clinical data are needed to address
cardiovascular safety concerns.
In October, the FDA declined to approve two proposed weight-loss
drugs fromArena Pharmaceuticals Inc. and
Vivus Inc.
The FDA closed the books on one of the highest profile
drug-safety matters in recent years by sharply curtailing
the use ofGlaxoSmithKline PLC's diabetes drug Avandia in
September after it was linked to increased risks of
heart attacks.
In October, the agency removedAbbott Laboratories' weight-loss
drug Meridia from the market, saying the drug
didn't work well enough to justify potential heart problems. A
month later, the makers of painkillers Darvon and
Darvocet agreed to take those drugs off the market, after many
years of concerns about an increased risk of
serious abnormal heart rhythms.
In December, the FDA said it would move to revoke the approval
of Roche's cancer drug Avastin for use in breast
cancer, saying the product didn't appear to help patients live
longer. Roche is appealing the move, which won't
affect the use of Avastin in other types of cancer.
The agency said this week it needed more time to review MannKind
Corp.'s inhaled-insulin product to treat
diabetes. It also said it needed until next March to review
Benlysta, a highly anticipated lupus drug from Human
Genome Sciences Inc. and GlaxoSmithKline.
Write to Jennifer Corbett Dooren
[email protected]
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