Thursday, December 3, 2009

Product Tidbits December 2009

1.  On 11/21/09 the FDA Advisory Committee voted Not to approved Xolair for children ages 6 to 11 years old with asthma. Efficacy was recognized but there may be safety concerns, which have come to light in adults only so far. The committee thought it was safer to wait until more data is available, rather than potentially subject children to risk.  I remember when I participated in Xolair's phase 3 testing in 1999.  This is an example of the slow and cautious approach to drug approval in the U.S., not that I'm objecting here, because safety should be weighted more than efficacy in children.
2. Inspire pharmaceuticals decided not to continue development of bilastine eyedrops, because of lack of demonstrated efficacy in U.S. drug trials.
3. ISTA Pharmaceuticals's bepotastine eyedrops (trade named Bepreve) were approved a a twice-day eye drop for itching eyes in allergic conjunctivitis in patients >2 years old.

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