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R&D news in brief

Our weekly round up of R&D news in brief

Femara wins wider FDA approval

Novartis' breast cancer drug, Femara, has been given US Food and Drug Administration approval to treat postmenopausal women with early-stage breast cancer after surgery.

The expanded approval is based on a study of more than 8,000 women with early-stage breast cancer after surgery. Results showed that after almost 26 months, women treated with Femara had a 19 per cent reduction in the risk of cancer returning, compared with women on tamoxifen.

Femara is in a class of drugs known as aromatase inhibitors and competes with AstraZeneca's Arimidex and Pfizer'z Aromasin.

Alkermes alcoholism drug given conditional approval

The US Food and Drug Administration has issued a conditional `approvable letter' for Alkermes' Vivitrol, an injectable form of an oral medication, naltrexone, to treat alcoholism.

If approved, Vivitrol would be the first product that Alkermes has developed on its own to reach the market.

Alkermes must provide additional data and finalise labelling to gain full approval. A six-month study published last April in the Journal of the American Medical Association involving 624 alcoholics found that those who received 380mg of naltrexone had a 25 per cent decrease in days involving heavy drinking.

AstraZeneca seeks new indication for Seroquel

AstraZeneca is seeking a new indication for its antipsychotic Seroquel, a drug currently approved to treat the manic phase associated with bipolar disorder.

The Anglo-Swedish company now wants to market the drug as a treatment for depressive episodes associated with bipolar disorder. If approved, it would be the only drug available that treats both depressive and manic episodes.

Seroquel is AZ's second biggest drug with Goldman Sachs projecting annual sales of $3.8bn by 2009.

30th September 2008

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