First new HIV drug in seven years gets approval
pharmafile | October 29, 2003 | News story | |
The first novel HIV treatment in seven years, Roche Fuzeon, is to undergo fast track approval in the US.
Fuzeon was granted a six-month priority review by the FDA and is expected to be available for distribution by the end of the month. In Europe, the CPMP has issued a positive opinion, recommending that the EMEA grant it a marketing licence.
Roche has, however, warned that demand for the drug may initially outstrip supply and is developing a US 'progressive distribution plan' to provide an uninterrupted supply of Fuzeon to patients once therapy has begun.
Analysts estimate peak sales of Fuzeon could reach between $700 and $900 million by 2007.
The drug's, a fusion inhibitor, was developed with biotech company Trimeris and is indicated for the treatment of HIV patients who have failed to show a response to existing antiretrovirals.
The drug's price over $20,000 per patient per year in Europe makes it the most expensive HIV medicine available, and has attracted considerable criticism. Roche says the price reflects the complex manufacturing process, which involves over 100 different steps, and the drug US price is expected to be similar.
"As more and more people with HIV are running out of options due to HIV drug resistance, new options are urgently required" ,said William Burns, Head of Roche Pharma. "With is novel mode of action Fuzeon meets this growing need."
The drug also represents a major advancement in the large-scale chemical synthesis of peptides, the cutting edge process perfected at Roche manufacturing facility in Boulder, Colorado.
Unlike current antiretrovirals, Fuzeon (enfuvirtide) prevents HIV replication by blocking the entry of the virus into immune cells. It is administered by twice-daily subcutaneous injection. Trimeris' second fusion inhibitor, T-1249, is in phase I/II trials and has also received FDA fast track status.
