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| Purple Walk for Lupus Awareness |
Everything you need to know about Tuesday's FDA panel recommendation for Human Genome Sciences therapy for Lupus, Benlysta. If approved Benlysta would be the first approved therapy in 50 years for Lupus. Friday the FDA released the notes for the upcoming panel review Tuesday, November 16th. Concerns for the panel Tuesday were an increased risk of suicide, risk of infection, and decreased efficacy in African-American patients, who are more prone to Lupus. Forbes' The Medicine Show Blog with Matthew Herper highlighted some of these concerns. Benlysta is teamed up with Glaxo SmithKline and if approved Human Genome Sciences will share marketing costs and profits. The expected market is anywhere between 1-3 Billion.
I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA. With that being said though, the FDA has rejected a lot of drugs this year and is very conservative. There are some concerns and more clinical trials could be advised before approval. We will have to see. Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus. The concerns dropped the stock and has investors spooked, but I still think that it will be recommended. I hope I am not wrong on this one.
For more on Tuesday's Decision
I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA. With that being said though, the FDA has rejected a lot of drugs this year and is very conservative. There are some concerns and more clinical trials could be advised before approval. We will have to see. Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus. The concerns dropped the stock and has investors spooked, but I still think that it will be recommended. I hope I am not wrong on this one.
Wikinvest--Glaxo (GSK)
Yahoo Finance--HGSI
Yahoo Finance--GSK
For more on Tuesday's Decision
