New Drug Approvals (NDAs) Slipped in 2010...Safety Job #1
Interesting WSJ article
Some Potential Blockbusters Suffered Delays Amid FDA's Tougher Safety Stance
WASHINGTON—The 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.
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 approved Acorda Therapeutics Inc.'s drug Ampyra to improve walking in MS patients.
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 by Watson 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 by Amylin 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 from Arena 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 of GlaxoSmithKline PLC's diabetes drug Avandia in September after it was linked to increased risks of heart attacks.
In October, the agency removed Abbott 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