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Tyverb is back in Europe

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Tyverb is back in EuropeThe European Commission has referred GlaxoSmithKline Plc’s breast cancer treatment Tyverb back for a fresh assessment by drugs regulators following new data from Europe’s biggest pharmaceuticals company.

Glaxo said on Tuesday that Tyverb, which is already on sale in the United States under the name Tykerb, had been referred back to the EU’s Committee for Medicinal Products for Human Use (CHMP) for further discussion.

It said the new information was from a standard pharmacovigilance review of clinical trial and post-marketing data.

Glaxo’s Tyverb Referred for More Discussion in Europe

GlaxoSmithKline Plc’s Tyverb breast cancer drug was sent back to a European regulatory panel after new data showed the medicine may raise the risk of liver damage, slowing final approval.

The European Commission returned the application to the region’s health-care regulator for further discussion, probably during its April 21-24 meeting, London-based Glaxo said today in an e-mailed statement. An agency committee recommended approval of Tyverb following a review in December.

Tyverb is one of the medicines Glaxo is relying on to help counter slowing growth in sales of its top-selling asthma drug Advair and diabetes pill Avandia and the loss of patent protection on other products. The commission was expected to issue a final decision on the breast cancer drug between Feb. 22 and March 8, Glaxo said.

“It’s not particularly good news,” analyst Nick Turner of Mirabaud Securities in London said in a telephone interview. “This is a drug that promised much but isn’t likely to deliver.”

The new data showed signs that the medicine can raise the level of liver enzymes in patients, a possible warning sign for damage to the organ. Elevated liver enzymes were seen in four out of 1,000 patients, and “generally returned to normal” after they stopped using the drug, according to the U.K. company.

Positive Profile

“GSK believes these data do not change the positive benefit-risk profile for Tyverb in the proposed indication,” Glaxo said in the statement.

Glaxo shares rose 38 pence, or 3.7 percent, to close at 1,054 pence in London trading.

The European Medicines Agency said in December that it recommended conditional approval of Tyverb for breast cancer that has advanced or spread to other parts of the body in patients with the HER-2 gene, which makes the disease more aggressive. Conditional approval is valid for one year while the company obtains more information about the medicine and its effectiveness, EMEA said at the time.

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