Washington, March 14 (Reuters): US health officials yesterday approved an eagerly awaited AIDS drug called Fuzeon that is the first in a new class of medicines to fight the deadly HIV virus.
The drug, developed by Roche Holding AG and Trimeris Inc, will provide a new option for AIDS patients running out of alternatives. Fuzeon works by stopping the HIV virus that causes AIDS from entering immune cells. Older medicines attack the virus inside cells.
Fuzeon, an injected drug also known as T-20, was approved for use with other anti-HIV drugs to treat advanced HIV infections in adults and children above six years of age. “The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection,” health and human services secretary Tommy Thompson said in a statement.
Some activists are worried about the drug’s price. A Roche official said the US cost would be similar to the approximately $20,000 per year previously announced for Europe.
There is still no cure for the virus that has killed 28 million people world-wide and infects 40 million now.
In the US, an estimated 850,000 to 950,000 people currently are living with HIV, with about 40,000 new HIV infections occurring every year, according to the US Centres for Disease Control and Prevention.
Multiple drug cocktails can keep AIDS at bay for years, but the virus mutates and eventually evades treatment. A significant percentage of patients with chronic HIV have developed a resistance to many of the existing medications.
“Fuzeon is going to be very important for people with no other options because they’ve become resistant to most drugs in the existing class,” said Bob Huff, editor of the Gay Men’s Health Crisis treatment newsletters.
In studies, Fuzeon given with other drugs suppressed virus levels in the blood in patients who had developed resistance to other regimens, Roche officials said. The drug is known as a fusion inhibitor. “If you’ve tried two, three or four multiple drug regimens and you’ve run out of options, Fuzeon provides a way out and a chance to improve your health,” George Abercrombie, president and chief executive of Roche’s North American Pharmaceuticals Operations, said in a recent interview.
The FDA said doctors and patients should watch for signs of pneumonia in people treated with Fuzeon. In clinical trials, bacterial pneumonia was uncommon but occurred with more Fuzeon patients than with patients not treated with the drug.
The Swiss drugmaker has announced Fuzeon will cost about $20,000 per year in Europe, and the price will be similar in the US, Abercrombie said. He said the high price was needed to enable Roche to continue supplying adequate amounts of the drug and will help sustain future research on other potential AIDS medicines.
Huff said Fuzeon’s price “is going to cause a lot of hardship on the state AIDS drug assistance programmes and on individuals who fall through the cracks of those programmes.”
“If the states are going to offer (Fuzeon), it means they have to cut something else or they have to limit the number of people that enrol, so that’s going to cause pain,” he added.
Roche officials have said they don’t expect Fuzeon to be suitable for use in Africa — the epicentre of the global AIDS epidemic — given high cost and complexity of production. In addition, most African patients have not yet developed resistance to existing drugs. “This is strictly a developed world product,” Huff said.
Fuzeon is seen as a key to help revitalise Roche’s pharmaceutical portfolio. The company expects demand to exceed supply initially while it works to increase production capability. Steps will be taken to make sure treatment is not disrupted for patients who start Fuzeon therapy, Abercrombie added.
Including those already involved in clinical trials and an early free-access programme, about 3,500 people worldwide will likely be on Fuzeon by the end of March.