Fuzeon makers say manufacturing slowdown will result in limited supply
BY Advocate.com Editors
December 21 2002 12:00 AM ET
Officials at pharmaceutical companies Trimeris and Roche on Wednesday announced 40% decreased production estimates for their HIV entry inhibitor Fuzeon, which is currently under review by the Food and Drug Administration. The drugmakers projected that by the end of 2003 they would be able to produce enough Fuzeon for 12,000 to 15,000 patients. By the end of 2004 about 32,000 patients will have access to the drug. The new estimates are down sharply from earlier projections that supplies would be adequate for 25,000 people in 2003 and 40,000 in 2004.
Fuzeon, the first drug in the new category of medications known as HIV entry inhibitors that aim to block HIV from attaching to and infecting T cells, is expected to receive FDA marketing approval in the first quarter of 2003. It will initially be available to patients who have failed other anti-HIV drug regimens.
Roche's manufacturing plant has completed its first commercial batches of Fuzeon, company officials said. The manufacturing process involves 106 separate chemical steps, 10 times the number required for the production of most drugs. Because of its difficult manufacturing process, Fuzeon is expected to cost between $10,000 and $15,000 per patient per year.
- WATCH: Mom Affirms Her Love in Son's Coming-Out Video
- Wives Want To Know If Their Husbands Are Gay
- Op-ed: We're Here, We're Queer, We're Not Part of a Pair
- Buck Angel Shuts Down Transgender Surgery Fundraising Site
- One Day in Big Gaylarious America
- Defending Anti-LGBT Laws, Putin Slams 'Genderless, Fruitless Tolerance'
- Women 3 Gay Lady-Related Golden Globe Nominations that Make Us Happy! 1 hour 38 min ago
- Coming Out WATCH: Mom Affirms Her Love in Son's Coming-Out Video 2 hours 1 min ago
- People Photo of the Day: DLB and Tom Daley Share a Moment in Houston 2 hours 9 min ago
- Marriage Equality Australia Re-Bans Same-Sex Marriage 2 hours 17 min ago
- Entertainment News Damien Lewis vs. Ian McKellen: Homeland Actor Apologizes 2 hours 19 min ago
- Politics WATCH: Right-Wing 'Documentary' Tries to Defend 'Ex-Gay' Therapy 2 hours 27 min ago
- Internet Wives Want To Know If Their Husbands Are Gay 2:44 PM