FDA Notifications

FDA meeting in May scheduled

The U.S. Food and Drug Administration (FDA) will hold a public meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss the safety and efficacy of new drug application (NDA) 22–505, tesamorelin acetate (EGRIFTA®) sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).

The meeting will take place on May 27, 2010, from 8 a.m. to 5 p.m. at The Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd. East, Adelphi, MD. You can contact the hotel directly at 301–985– 7300 for directions or to arrange accommodations.

The meeting will be open to the public, and no registration is required.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to Paul Tran, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: paul.tran@fda.hhs.gov on or before May 13, 2010.

Etravirine label updated by FDA

The U.S. Food and Drug Administration (FDA) recently updated the label for etravirine (Intelence®) to include drug-drug interaction information between etravirine and fluconazole, voriconazole, lopinavir/ritonavir tablets and clopidogrel. The major changes to Section 7 Drug Interactions are summarized below.

In addition the magnitude of the interaction for etravirine in the presence of fluconazole, voriconazole and lopinavir/ritonavir tablets can be found in section 12.3 Pharmacokinetics.

Please also refer to http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf to view the complete updated label.

Etravirine - fluconazole and voriconazole: Co-administration of etravirine and fluconazole or voriconazole significantly increased etravirine exposures. The amount of safety data at these increased etravirine exposures is limited; therefore, etravirine and fluconazole or voriconazole should be co-administered with caution. No dose adjustments of Intelence, fluconazole or voriconazole is needed.

Etravirine - lopinavir/ritonavir tablets: Intelence and Kaletra (lopinavir/ritonavir) tablets can be coadministered without dose adjustment.

Etravirine - clopidogrel: Activation of clopidogrel to its active metabolite may be decreased when clopidogrel is co-administered with Intelence. Alternative to clopidogrel should be considered.