Actually, under the no harm, no foul policy of the FDA, Panretin did get an 8-0 vote. The lone negative vote was based on the perception that the drug "wasn't worth it", not that the drug was unsafe or didn't work.
The FDA developed a "no harm, no foul", policy to allow the marketplace to determine if the drug was or wasn't "worth it". Thus, products that were safe and efficacious would be approved, and Drs and patients would determine if the costs was worth the benefit.
It's somewhat interesting that the patient sought to take on the responsibility for determining that the drug wasn't worth it, instead of letting individual patients decide for themselves. Of course he may have realized that the drug would be approved, in spite of his dissenting vote, and his vote was for more effective drugs.
However, most drugs, especially when used as monotherpy, achieve less than ideal results, including PIs and nucleoside analogs. It takes a great deal of money and clinical trials to optimize treatment and combinations generally are more effective than single agents.
I don't think that LGND expected AIDS patients with KS to abandon current therapies for treating HIV and in fact a high percentage of patients using the Panretin were on therapies using PI cocktails.
The projections by analysts after the FDA panel rec was released, was in line with estimates before the release. Legg Mason and Bear Stearns expect annual Panretin revenues to grow to the $20-$50 million range and LGND is currently conducting trials for treating KS with an oral version of Panretin. |
