FDA Wants New Study From Abraxis

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A Food and Drug Administration advisory committee on Thursday told Abraxis BioScience Inc. that it needs to conduct a well controlled randomized clinical trial before it would be allowed to market its Abraxane drug for wider use in breast cancer patients.


In a 13-1 vote, the panel said the FDA should require trials, which may take at least five years, before deciding whether to approve the wider use, which would significant boost sales of Los Angeles-based generic drugmaker’s first brand-name product. The FDA is not bound by the panel’s vote but usually follows the advice of its outside experts.


Abraxis received approval last year to sell Abraxane for limited treatment of advanced breast cancer patients who had not benefited from established chemotherapy regimes. An FDA endorsement for expanded use would help the company meet Wall Street expectations. Abraxane had $134 million in sales last year, but sales so far this year have not grown fast enough to satisfy analysts.


“We are encouraged by the ODAC panel’s recommendation and we intend to move as quickly as possible to discuss the next steps with the FDA,” Dr. Michael Hawkins, Abraxis’ chief medical officer, said in a statement.


Abraxane is an injectable form of the chemotherapy drug paclitaxel, which fights cancer growth. Bristol-Myers Squibb Co.’s Taxol use the same active ingredient, but Abraxis’ scientists combined paclitaxel with a protein that makes it easier for the body to absorb. Abraxis had wanted the FDA to expand Abraxane’s use based on already available Taxol studies, before its own longer term safety trials were completed.


Shares of Abraxis were down 1 percent, at $24.84 in midday trading. Shares of AstraZeneca Plc, which has a U.S. co-promotion deal for Abraxane, were down less than 1 percent to $62.91.

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