FDA Roundup: BioMimetic Therapeutics Inc.
Elsewhere, Genentech Inc. (S. San Francisco CA), a member of the Roche Group, won approval for a longer length of therapy for Valcyte in adult kidney transplant patients at high risk for cytomegalovirus disease. Cytomegalovirus is a common virus that infects most people and rarely causes problems. However, it can cause serious infections in people who have received organ transplants or in immunodeficient patients, such as those with HIV or AIDS. Genentech said data showed that longer, preventive treatment with Valcyte cut the incidence of the disease in high-risk patients from 36.8% to 16.8% a year after receiving a transplanted kidney.
And Watson Pharmaceuticals Inc. (Corona CA) and HRA Pharma (Paris FRA) won approval for an emergency contraceptive that women can take up to five days after sex and will compete with Teva Pharmaceutical Industries Ltd.'s Plan B morning-after pill. Watson will start selling the pill, to be called Ella, in the final three months of this year. The drug will be dispensed as a single dose and requires a prescription. Teva's Plan B, which works for as much as 72 hours after unprotected sex, is available without a prescription for women ages 17 and older. Closely held HRA has been selling the drug in 22 European countries since October 2009.
In other news, GlaxoSmithKline Plc (Brentford GBR) and Valeant Pharmaceuticals Inc. (Aliso Viejo CA) won the backing of an advisory panel for a new drug to reduce seizures in patients with epilepsy. The committee of FDA advisers voted 11-0 with two abstentions that urinary problems with the drug, Potiga, could be managed with patient monitoring. The panel voted 13-0 that Potiga was effective for use with other epilepsy drugs for patients still having seizures. Analysts forecast peak annual sales of the drug ranging from $200 million to $800 million. The FDA usually approves medicines that win the support of advisory panels, although it isn't required to do so.
And the FDA warned doctors and patients that an anti-seizure drug from GlaxoSmithKline Plc can cause rare inflammation of the brain and spinal cord. The agency said Thursday it is working with the British drugmaker to add new warnings and labeling information to the drug Lamictal. The agency said it has received reports of 40 cases of aseptic meningitis since Lamictal's approval in 1994 and last November. Thirty-five patients needed to be hospitalized, the agency said in a statement. The symptoms usually emerged within the first month and a half of treatment. Aseptic meningitis is a dangerous inflammation of the brain and spinal cord that can cause headache, fever, chills and vomiting. The problem can be caused by viruses, toxins and certain medications. Treatment for the illness, which usually resolves itself in two weeks, generally involves pain medications. Lamictal is part of the anti-seizure family of medications. The drug, which posted sales of $778 million last year, is also approved by the FDA to treat manic depression.
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|Date:||Aug 16, 2010|
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