PFIZER HIV DRUG HELD BECAUSE OF SAFETY CONCERN
- AIDS might soon have a treatment as an experimental Pfizer Inc AIDS pill, the first of its kind, against the Human Immunodeficiency Virus (HIV) was effective in suppressing it. Health officials however, are concerned about the safety of the drug, which now seeks the approval of the Government advisors.
- The Food and Drug Administration staff would consult an advisory panel for advice “regarding the possible need for special labeling as well as whether additional clinical trials should be performed to address particular safety issues”, they said.
- The new drug-Maraviroc belongs to a class of drugs called CCR5 antagonists and could be the first drug in the market to block the CCR5 co-receptor that provides the main entrance for the virus into cells.
- FDA has been known to follow the recommendation of experts though it is not obligatory. A panel of experts will vote Tuesday to decide the fate of the drug. If the risks of cancer and infection are found to be serious, Maraviroc may not be approved.
- If approved, Maraviroc sales may touch $US500 million, believe the industry analysts.
- Safety concerns are high as earlier medicines, under development were associated with various risks. For instance, signs of liver damage appeared in some patients because of which British drug maker GlaxoSmithKline plc decided to quit its drug aplaviroc. With the use of a similar drug, lymphomas have been found to develop in several patients as reported by Schering-Plough Corp., which is stll performing the trials.
- According to the FDA reviewers, Maraviroc did not cause lymphoma in Pfizer studies but a ‘modest’ increase in liver-related abnormalities was found. Animal studies reveal that Maraviroc may also lead to heart problems.
- Dr Jacob Lalezari, the lead researcher for Pfizer's trials in the US, said AIDS patients, resisting older treatments and consequently running out of options had responded well to the drug.
- "I don't have any fears or concerns certainly about the safety data generated to date," said Lalezari, director of Quest Clinical Research at the University of California at San Francisco. But he added that "you don't know about five- or ten-year safety issues until a drug's been out five or ten years."
- The experts will soon put forward their opinions as the rest of us hope for the dreaded disease to find a cure.
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