PHARMACY

PhRMA: More than 70 drugs, vaccines under development for HIV/AIDS

BY Alaric DeArment

WASHINGTON — Drug companies have made "remarkable progress" in treatment options for patients with HIV and AIDS, according to two new reports from a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America released a report Thursday showing 73 drugs and vaccines under development for the 1.2 million people in the United States living with HIV. A second report, a white paper sponsored by PhRMA and published by Boston Healthcare Associates, tracks advancements in treatment that have made HIV a manageable, chronic condition. Titled Recognizing the Value of Innovation in HIV/AIDS Therapy, the report shows that while the number of people living with HIV increased by 28% between 1996 and 2000, due primarily to rising survival rates, hospitalization rates fell by 32% during the same period.

"Incredible strides have been made in the battle against HIV/AIDS, but the disease still poses a global threat, and the collaborative path to further solutions for patients will be complex," PhRMA president and CEO John Castellani said. "The nearly 75 medicines in development offer great hope for better treatment and prevention of HIV/AIDS in the years ahead."

Some of the new treatments under development include an antisense gene therapy that uses genetic material derived from the HIV-1 strain of the virus to remove its disease-causing aspects; a transdermal vaccine that helps suppress virus replication and destroys infected cells; and a first-in-class medicine intended to prevent the virus from attaching to new cells and breaking thorugh the cell membrane.

"Together, these new reports highlight how far we have come in the fight against HIV/AIDS over the last few decades," Castellani said. "Through a series of complex steps and incremental gains in knowledge, therapeutic options for patients with HIV/AIDS are transforming the treatment paradigm and prolonging lives."


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PHARMACY

FDA panel backs J&J tuberculosis drug

BY Alaric DeArment

RARITAN, N.J. — A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

J&J subsidiary Janssen Research & Development said the FDA’s 18-member Anti-Infective Drugs Advisory Committee voted unanimously that the results of clinical trials of the drug bedaquiline supported its approval for treating pulmonary multi-drug resistant tuberculosis as part of drug-combination therapy. The committee voted 11-7 that the drug was sufficiently safe for this use as well. The FDA isn’t required to follow advisory committee votes, but usually does.

"We are pleased with the committee’s recommendation and look forward to working with the FDA to bring this important therapy to patients who suffer from MDR-TB," Janssen global head of development for infectious diseases and vaccines Wim Parys said. "The positive recommendation from the FDA advisory committee is an important step toward achieving that goal."

Janssen said the the FDA assigned a priority review designation to the regulatory application for the drug, which the company filed in June, seeking accelerated approval.


 

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FDA approves Mylan overactive bladder drug

BY Alaric DeArment

PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.


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