Name/CompanyApproval Dates and Comments

Emtricitabine + tenofovir disoproxil fumarate

Gilead Sciences, Inc.

In July 2012, the FDA approved once-daily oral emtricitabine and tenofovir disoproxil fumarate, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. It is the first agent to be approved for HIV prevention in uninfected adults, a strategy known as pre-exposure prophylaxis (PrEP).

Collagenase clostridium histolyticum

Actelion Pharmaceuticals
Auxilium Pharmaceuticals

Health Canada approved this novel, first-in-class biologic in July 2012 for the injectable treatment for Dupuytren’s contracture in adults with a palpable cord. The injected enzymes dissolve and weaken the contracted collagen cord. This is the only nonsurgical option for Dupuytren’s disease.

Device News

Computer-assisted system for hair follicle harvesting

ARTAS™ System
Restoration Robotics, Inc.

The European Commission granted CE Mark of approval in July 2012 to the first physician-controlled, computer-assisted technology that harvests individual follicular units directly from the scalp of men diagnosed with androgenetic alopecia with black or brown straight hair. It combines several features including an image-guided robotic arm, imaging technologies (e.g., digital mapping), small dermal punches, and a computer interface. The system identifies and harvests individual follicular units to implement the follicular unit extraction technique during hair restoration procedures.

OTC HIV test

OraQuick® In-Home HIV Test
OraSure Technologies, Inc.

The FDA has granted marketing clearance in July 2012 to this first and only rapid OTC human immunodeficiency virus test that can detect antibodies to both HIV-1 and HIV-2 with an oral swab and provide results in 20-40 minutes. Based on a US phase 3 study, sensitivity was 93% and specificity was 99.98% using saliva. The FDA advises consumers that positive test results using this kit must be confirmed by follow-up laboratory-based testing. Also, the test can produce false negative results for reasons that include the occurrence of HIV infection within 3 months before testing.

Herpes simplex virus test

IMDx HSV-1/2 for Abbott m2000

The European Commission granted marketing clearance in July 2012 to this high-throughput molecular test designed and developed for the Abbott m2000 System. This automated molecular test detects herpes simplex virus (HSV) viral DNA and determines whether it is HSV-1 or HSV-2 in male and female genital or oral lesions and cerebral spinal fluid.

Drug News

According to a systematic review and meta-analysis presented at the Annual Congress of the European League Against Rheumatism (EULAR) in Berlin Germany, June 6-9, 2012, patients with inflammatory rheumatic diseases treated with anti-tumor necrosis factor (anti-TNF) agents (e.g., adalimumab, etanercept, and infliximab) have a 75% greater risk of developing herpes zoster (shingles), when compared with patients who received therapy with disease modifying anti-rheumatic drugs (DMARDs). The study authors conducted an extensive literature search, which included a total follow up of 124,966 patient years (PY) (74,198 PY in the biologics group and 50,768 PY in the DMARD group). Based on their findings, the investigators raise questions about timing of prophylactic vaccine administration for at risk patients and urge vigilance in monitoring for early signs and symptoms of herpes zoster during treatment with anti-TNFs drugs.