New and Innovative Pfizer HIV Drug Approved
Drugs giant Pfizer yesterday confirmed that approval had been given by the US Food and Drug Administration for its pivotal Selzentry Aids drug. The leader of a new wave of orally-taken HIV medicines, Selzentry is unique in its conception. While the current generation of drugs target the AIDs virus itself, Pfizer's product prevents the HIV virus, responsible for the development of AIDS, from gaining entry to normally-functioning immune cells. It does this by effectively forming a barrier over the CCR5 co-receptor that otherwise would allow HIV through to the cells.
The limits of the approval now given by the US FDA are that it be used in patients who have previously trialled themselves on alternative medication, or in those in which it can be proven that their strain of HIV is connected to the CCR5. According to the FDA, up to 60 per cent of patients who have been medicated by other AIDS-aimed drugs would fall under this specification.
What has not yet been confirmed is the effect Selzentry would have on adults or children who have not been administered with previous HIV drugs.
The US regulatory body further detailed that a severe warning (known as a "black box") would be written into Selzentry's packaging, in respect of it possibly causing the onset of toxic liver. Furthermore, its label will highlight the risk of heart attacks resulting from its use. Patients who have so far taken the drug have reported a wide number of side effects, which include abdominal pain, dizziness, fevers and coughs.
According to Pfizer itself, Selzentry should be on the market by the end of September 2007. In studies undertaken by the pharmaceutical leviathan, around 45 per cent of those assessed saw their strand of HIV reduced to levels where it was undetectable. This compared to 23 per cent, who achieved the same result using a placebo.
Pfizer is relying on medicines such as Selzentry to boost profits, amidst the recent loss of patents on several of its products, alongside the competition lining up to take on its market-topping cholesterol drug, Lipitor.
Experts within the Pharmaceutical Industry are predicting that Selzentry will generate sales figures of approximately $500 million for the firm within four years.
Source - Pharmaceutical International's Assistant Editor
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