National AIDS Fund announces grants
Senate acts to ease states’ ADAP crisis
Tesmorelin wins unanimous FDA panel approval
Good news—the fixed dose combination of Truvada and the still-in-the-works drug TMC278 met primary efficacy points in clinical studies of people taking HIV medication for the first time (treatment-naïve). The combination was found to be non-inferior to Sustiva/Truvada based on the proportion of people achieving less than 50 copies viral load at 48 weeks.
Gilead Sciences, the maker of Truvada, also recently announced a bioequivalent formula of Truvada and TMC278 has been achieved; that is, a formulation that achieves the same blood levels of medicine when the medications are taken together as when they are taken separately. TMC278 (rilpivirine hydrochloride) is being developed by Tibotec, and is a non-nucleoside reverse transcriptase inhibitor, like Sustiva. If it succeeds, the new fixed dose combination will become the second HIV drug on the market to comprise a complete regimen in one tablet taken once daily. (The first was the ultra-popular Atripla, which combines Truvada with Sustiva.)
National AIDS Fund announces grants
On May 13, the National AIDS Fund (NAF) announced the awarding of major grants that will enable more than 35 community-based organizations to help improve access to care for HIV-positive people in Chicago, New York, and Oakland/San Francisco, and the states of North Carolina and Louisiana. According to the press release, “The grant awards provide an opportunity for geographically and culturally diverse organizations within a region to combine their expertise in the development of community-driven solutions to help enable greater access to HIV/AIDS care and treatment.”
The community grants were made possible through a separate grant from pharmaceutical company Bristol-Myers Squibb (BMS) to the NAF. The collaboration between BMS and the NAF is one of the key components of Positive Charge, a BMS initiative that aims to enable people living with HIV/AIDS to access care and treatment; contribute to the scientific agenda; and demonstrate advocacy leadership.
—Sue Saltmarsh
Senate acts to ease states’ ADAP crisis
In a press release issued by the Community Access National Network (CANN) on May 26, CANN commended North Carolina senator Richard Burr and Senator Tom Coburn of Oklahoma “for their leadership in solving the ongoing AIDS Drug Assistance Program (ADAP) crisis. The ACCESS ADAP Act, introduced in the Senate, provides $126 million to ADAP for the remainder of fiscal year 2010 to address the immediate need of individuals on waiting lists, to prevent these lists from expanding to more states, and to recover every patient who has been taken off their comprehensive drug regimen.”
According to the release, the money for ADAP is to be allocated from funds that are to be used for improving and preserving health care, as well as promoting prevention, and wellness.
“At a time when waiting lists are growing with no end in sight and these patients no longer have access to their life-saving drugs through ADAP, there couldn’t be a more appropriate funding stream to deal with the preservation of healthcare and the promotion of these individuals’ wellness,” commented William Arnold, executive director of CANN. “Keeping folks alive is stimulus.”
—Sue Saltmarsh
Tesmorelin wins unanimous FDA panel approval
On May 27, Theratechnologies announced that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee recommended by a 16 to 0 vote that tesamorelin, a growth hormone releasing factor, should be granted marketing approval by the FDA based on a favorable benefit-risk profile, for the treatment of excess abdominal fat in HIV-positive patients with lipohypertrophy (excess fat surrounding organs in the abdominal area), a condition that affects up to 30% of people living with HIV.
Although advisory committees provide their recommendations to the Agency, the final decisions on marketing approvals are made by the FDA. The FDA has indicated that the target date for the FDA to complete its review of the tesamorelin New Drug Application, will be July 27, 2010.
In 2008, Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, Inc., an affiliate of Merck KGaA in Darmstadt, Germany, for the exclusive commercialization rights to tesamorelin in the United States.
Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies said, “The Advisory Committee recommendation is another important step forward for the Company. It is especially significant for those patients who suffer from this serious metabolic complication, where today no treatment option exists.”
Positively Aware editor Jeff Berry was one of three public speakers testifying to the committee on the importance this drug could play in the lives of people living with HIV. For a first-hand account of the hearing which led to the panel’s vote, see “The Power of Advocacy,” on page 27.
—Sue Saltmarsh
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