FDA Notifications

Tessamorelin approved for lipodystrophy

On Nov. 10, 2010, the Food and Drug Administration (FDA) approved tessamorelin (Egrifta®) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs (visceral body fat).

The condition is associated with many antiretroviral drugs used to treat HIV. Egrifta was approved to induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy.

Tessamorelin, the first FDA-approved treatment for lipodystrophy, is a synthetic growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.

The presence of excess visceral fat accumulations associated with this condition may contribute to other health problems as well as affect a patient's quality of life. Whether tessamorelin decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.

Tessamorelin was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received tessamorelin during a 26-week, placebo-controlled period. In both studies, patients treated with tessamorelin experienced greater reductions in abdominal fat (15 - 17%) as measured by CT scan, compared with patients receiving another, non-active injectable solution (placebo). Some patients reported improvements in their self-image.

The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritus), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.

Tessamorelin was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Massachusetts-based EMD Serono. Product labeling for Egrifta will be made available soon on Drugs@FDA.

Pediatric abacavir tablets approved

On Nov. 29, 2010, the Food and Drug Administration granted tentative approval for a formulation of abacavir sulfate tablets, 60 mg, made by Matrix Laboratories Limited of Hyberdad, India, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection. The tablet formulation is intended for pediatric use, allowing dosing for patients weighing as little as 5kg, and is unique in that it can be dispersed in liquid for patients unable to swallow tablets.

FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR program.

As with all applications, FDA conducts an on-site inspection of the manufacturing facilities and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Nominations open for Antiviral drug panel

The Food and Drug Administration (FDA), to assist in its mission to protect and promote the public health, uses 49 committees and panels to obtain independent expert advice on scientific, technical, and policy matters.

The FDA is seeking technically qualified medical/scientific consultants to serve as members of its Antiviral Drugs Advisory Committee for future panels to consider potential direct-acting antivirals (DAAs) for the treatment of hepatitis C — specifically hepatologists or other medical doctors who treat a substantial number of hepatitis C patients. Consultants should have experience interpreting and analyzing detailed scientific data, and understand its public health significance.

Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. Potential conflicts include, but may not be limited to: employment with a pharmaceutical sponsor, having financial interests or stock in pharmaceutical companies developing DAAs, participating as an investigator in pivotal studies of DAAs in development, being chair of a department in which colleagues are investigating a DAA, or receiving substantial amounts of reimbursement from DAA sponsors for consulting services or presentations.

Advisory Committee meetings are convened in the Washington D.C. metropolitan area, typically for two days twice a year. Committee members are appointed as Special Government Employees, and receive a salary for each meeting day as well as travel and per diem costs.

General information about FDA Advisory Committees can be found at http://www.fda.gov/AdvisoryCommittees/default.htm and information about membership can be found at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/default.htm.

If you are a medical doctor meeting the criteria above, or would like to nominate a medical doctor with hepatitis C expertise, You may submit your information by:

E-mail to cv@oc.fda.gov or mail to:

Food and Drug Administration;
Advisory Committee Oversight and Management Staff;
10903 New Hampshire Avenue, Bldg. 32, Rm. 5101;
Silver Spring, Maryland 20993-0002.

Please include full contact information of any person you are nominating.