Monday, July 13, 2009

A New Antihistamine Named Bilastine

Bilastine is a new antihistamine that is being investigated around the world. Bilastine will be taken orally for allergic rhinitis and in eye drops for allergic conjunctivitis. Bilastine has been approved in a few European countries. However, bilastine is not approved for use in the U.S. yet. The manufacturer, Faes Farma, has partnered with Inspire Pharmaceuticals in the U.S. The FDA has required additional studies to determine if bilastine has any adverse effects on the heart, specifically lengthening of the QT interval. No word on the status of these studies. I expect this process could take two years, before approval in the U.S. and then additional delay as marketing and production gears up.

1 comment:

Ciscu said...

Hi Neil!

Just to update you in this new Antihistamine named Bilastine.

-Bilastine has not been yet approved for use in Europe. Bilastine has been filed for approval this year at the EMA, on February 27th, in 29 European countries, by decentralized procedure acting Germany as reference member state. Expected to be approved end 2009/beginning 2010.

-Faes Farma licenses Bilastine to Hikma Pharmaceuticals LLC for the Middle East & North Africa (“MENA”) region. (16th July 2009)

-Faes Farma licenses Bilastine to Vianex in Greece. In co-marketing with Menarini.(29th June 2009)

-Faes Farma licenses Bilastine to Merck Serono in India. (13th March 2009)

-Faes Farma licenses Bilastine to Italian Menarini which it will market the drug in 51 countries, including EU in whole. (18th December 2007)

-Faes Farma licenses Bilastine to Yuhan Corporation in South Korea. (23th November 2007)

-Inspire is not longer the partner in the USA.

-Faes Farma is in conversations with Pfizer in order to complete the co-marketing agreements in Europe and in the big emergent

Hope it helps.



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