Europe speeds away

EC's fast track plan, FDA hurdles, could drive antibiotics developers to Europe

The European Commission's new action plan to combat antimicrobial resistance could further widen the regulatory gap between the U.S. and Europe, which is already at the point where some physicians worry companies will no longer seek FDA approval of their antibiotics.

Indeed, the U.S. agency's insistence on what companies and clinicians say are clinically irrelevant endpoints has already resulted in one drug being approved in Europe this year but not in the U.S. And FDA's requirements for what companies and doctors say are unfeasible clinical trial designs have already lead some companies to wait for the agency to change its tune before performing Phase III studies for U.S. approval.

The U.S. now looks to be falling farther behind with the EC's announcement last month that it is committed to implementing faster approval processes for new antibiotics and coordinating to achieve "adequate market and pricing conditions for new antibiotics" in the EU.

The Ketek break

The number of new antibiotics reaching the market in the U.S. has been steadily declining as pharmas leave the space for more attractive opportunities.

Antibiotics do not guarantee great financial returns because they are used for short courses, and new antibiotics are often held in reserve to reduce the likelihood of resistance. Plus, there is a general sense that antibiotics should be cheap.

"Starting in the 1990s, larger companies began to go after chronic diseases like high cholesterol and hypertension that should attract a larger market because of long duration of therapy, and diseases like rheumatoid arthritis and cancer that had higher individual price points than did your traditional antibiotic," said Rick Winningham, chairman and CEO of Theravance Inc.

"Why did small companies continue to do antibiotic R&D? In the late 1990s and early part of the last decade, clinical trial designs were fairly clear, trials were short and you could leverage a little bit of insight to improve treatment," Winningham told BioCentury.

This regulatory environment changed when FDA starting putting up additional requirements in 2006 following postmarketing reports of severe liver injury in patients taking Ketek telithromycin from Sanofi. The agency approved the drug in 2004.

After congressional investigations and a series of advisory panels, FDA removed acute bacterial sinusitis (ABS) and acute exacerbations of chronic bronchitis (AECB) from Ketek's label in 2007, leaving only community acquired pneumonia (CAP) (see BioCentury, Dec. 18, 2006).

FDA also began revisiting clinical

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