The first stem-cell therapy has been recommended for approval by the Committee for Medicinal Products for Human Use, among seven new medicines to clear one of the last hurdles to market.
Chiesi Farmaceutici’s orphan drug Holoclar has been given the thumbs up - as the first advanced therapy medicinal product (ATMP) containing stem cells - for the treatment of moderate-to-severe limbal stem cell deficiency due to physical or chemical burns to the eyes in adults.
It is also the first medicine recommended for LSCD - a rare eye condition that can result in blindness - potentially offering an alternative to transplantation and increasing the chances of a successful corneal transplant where the injury has caused extensive eye damage, the CHMP said.
A positive opinion was also issued for Orexigen Therapeutic’s Mysimba (naltrexone/bupropion) for weight management in adults who are obese, or those overweight with one or more related complications, alongside a reduced-calorie diet and physical activity.
The endorsement comes on the back of clinical trials showing that more patients treated with Mysimba achieved clinically-relevant weight loss than patients treated with placebo.
On the safety side, the Committee noted that uncertainties remain over the drug’s long-term affect on the heart, but stressed that interim clinical data was “reassuring” and that a second study is planned in order to continue monitoring cardiovascular safety. Nevertheless, it has recommended that patients should be monitored after 16 weeks’ treatment and only allowed to continue treatment if they have achieved at least 5% weight loss.
Elsewhere, recommendations were handed out for: Zambon’s Xadago (safinamide) for Parkinson’s disease; Durata Therapeutics’ Xydalba (dalbavancin) for the treatment of skin and skin structure infections; Aptalis Pharma’s orphan drug Quinsair (levofloxacin) for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis; and generic medicine Clopidogrel ratiopharm (clopidogrel) for prevention of myocardial infarction, ischaemic stroke, peripheral arterial disease and acute coronary syndrome, as well as atherothrombotic and thromboembolic events in atrial fibrillation.
Finally, a positive opinion was issued for Genzyme Europe’s informed consent application for Tasermity (sevelamer hydrochloride) for the control of hyperphosphataemia in adults receiving dialysis. In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure.
The CHMP has now recommended 82 new medicines for approval in Europe this year.