The latest set of opinions from the European Medicines Agency have brought good news for Germany's Biofrontera Bioscience and especially for the Australian firm Pharmaxis.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Biofrontera's Ameluz (5-aminolevulinic acid) for the treatment of actinic keratosis. However, more eye-catching was a positive opinion for Pharmaxis' cystic fibrosis Bronchitol (mannitol).
The recommendation comes after the CHMP rejected the drug in June amid safety concerns about its use in children with CF. News of the reversal sent Pharmaxis shares soaring over 60%.
However, the Committee again refused marketing authorisation for Amsterdam Molecular Therapeutics' gene therapy product Glybera (alipogene tiparvovec) for patients with lipoprotein lipase deficiency. It turned down the drug in June, saying there was insufficient evidence that its benefits outweigh its potential risks.
Other highlights of the CHMP meeting included recommendations to expand the labels on GlaxoSmithKline's human papillomavirus vaccine Cervarix and AstraZeneca/Bristol-Myers Squibb's diabetes drug Onglyza (saxagliptin). It has also begun a review of Servier's strontium-ranelate-containing osteoporosis drugs Protelos and Osseor, to determine whether reported cases of venous thromboembolism and drug rash with eosinophilia and systemic symptoms affect their benefit-risk profile.
The EMA also noted that after a review of angiotensin II receptor antagonists (ARBs) it has concluded that the evidence does not support any increased risk of cancer in patients using these drugs. However, it has initiated a new investigation into the safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and possible cardiovascular risk.