FDA concerns remain over new use for Schering drug

The U.S. Food and Drug Administration has "outstanding concerns" about Schering-Plough Corp's bid to market its drug PegIntron to treat certain skin cancer patients who also undergo surgery, the drugmaker said on Friday.

The company is seeking FDA permission to sell the injectable drug for melanoma. But the agency declined against approving the new use, at least right now, instead issuing a complete response letter about remaining issues.

"Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PegIntron melanoma filing," the company said in a statement.

Schering did not say what the FDA's concerns were and company spokeswoman Mary-Francis Faraji said the drugmaker had no additional comment.

PegIntron, a type of alpha interferon protein-based drug that is self-injected once-a-week, is already approved for liver disease. The new use would allow it for patients whose melanoma has spread to the lymph nodes and require surgery to remove the cancer and the nodes.

Earlier this month, an FDA panel of outside experts narrowly recommended approval of the drug despite its toxic side effects. Some panelists as well as FDA staff reviewers also questioned whether the drug actually helped people live longer or just increased the time before cancer recurred.

Side effects with PegIntron include heart problems and depression.

Schering's Intron A, which is already approved for melanoma after surgery, has the same active ingredient as PegIntron but must be given intravenously five times a week for four weeks at a doctor's office.

Shares of Schering were off 23 cents, or less than one percent, at $28.20 on the New York Stock Exchange.

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FDA OKs New Schizophrenia, Bipolar Drug

The FDA has approved a new drug called Saphris to treat schizophrenia and bipolar I disorder in adults.

"Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy," Thomas Laughren, MD, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, says in a news release.

"Effective medicines can help people with mental illness live more independent lives," Laughren says.

The FDA notes that the most common symptoms of schizophrenia include hearing voices or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid.

Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, fast talking, impulsive behavior, and a decreased need for sleep.

Saphris, which comes in tablets, belongs to a class of drugs called atypical antipsychotics.

The FDA approved Saphris based on clinical trials in which the drug trumped a placebo at reducing schizophrenia symptoms in adults and other trials in which Saphris was better than a placebo at treating symptoms of bipolar disorder.

In clinical trials, the most common side effects reported by schizophrenia patients being treated with Saphris were the inability to sit still or remain motionless, decreased oral sensitivity, and drowsiness.

The most common side effects in clinical trials of patients treated with Saphris for bipolar disorder were drowsiness, dizziness, movement disorders other than the inability to sit still or remain motionless, and weight gain.

All atypical antipsychotic drugs carry a "black box" warning, the FDA's sternest warning, alerting prescribers about an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. Saphris isn't approved for those patients.

Saphris is made by the drug company Schering-Plough.

Source : www.webmd.com

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