Europe's CHMP to review of ARBs for possible cancer risk; starts Invirase assessment

The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) announced, along with a string of positive recommendations for new drugs published in The Pharma Letter yesterday, that it has begun looking at the possible risk of cancer in patients taking angiotensin II receptor blockers (ARBs), a class of drugs which generated $25 billion of sales last year.

This follows the publication of a meta-analysis earlier this month in The Lancet by Ilki Sipahi of the University Hospitals Case Medical Center in Cleveland, USA, and colleagues, reviewing nine randomized controlled trials involving almost 95,000 patients, which suggests that these medicines may be linked with a modestly increased risk of new diagnoses of cancer when compared with placebo or other heart medicines (TPL June 14).

The analysis showed that patients randomized to receive ARBs had a 7.2% risk of developing a new cancer, compared to a 6% risk among patients in control groups. The researchers note, however, that "it is not possible to draw conclusions about the exact risk of cancer associated with each particular drug." In the meta-analysis, 86% of patients received Boehringer Ingelheim's Micardis (telmisartan.) The German drug major strongly defended its product, saying that telmisartan is one of the best researched medicinal (TPL June 14).