Bayer: FDA will speed review of 2 respiratory meds

AP News
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Posted: Nov 24, 2014 5:51 PM

WHIPPANY, N.J. (AP) — Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics.

Bayer HealthCare, based in Whippany, New Jersey, said Monday the Food and Drug Administration has designated two of its experimental treatments as qualified infectious disease products. Such drugs for potentially deadly infections get put on a fast track for approval and earn an extra five years' of market exclusivity.

One of the Bayer treatments, Amikacin Inhale, is an aerosolized solution being tested in addition to intravenous antibiotics in adult pneumonia patients on breathing machines. The other, ciprofloxacin dry powder, is being tested to see if it prevents or delays lung complications in bronchiectasis, a chronic dilation of airway passages.