Chiesi gets first-ever European stem cell nod
pharmafile | December 19, 2014 | News story | Sales and Marketing | Chiese, Chiesi, EMA, Holoclar, LSCD, MHRA, Stem cells, orexigen
Chiesi has received the first approval for an advanced therapy medicinal product containing stem cells for use in Europe.
The regulator described the Italian company’s treatment as an innovative therapy that will be a ‘major step forward’ for patients.
Holoclar is a treatment for moderate to severe forms of limbal stem cell deficiency (LSCD), a rare eye condition caused by physical or chemical burns to the eye that causes blindness. The stem cells are grown in a laboratory using cell culture, and transplanted into the cornea of the affected eye to restore sight.
This is the first medicine recommended for LSCD, which is estimated to affect around three in 100,000 people in the European Union. Holoclar has been given orphan drug status, and Enrica Alteri, head of EMA’s human medicines evaluation division, says the decision “represents a major step forward in delivering new and innovative medicines to patients”.
But the EMA recommended a conditional marketing authorisation because the clinical trial data for Holoclar is “based on retrospective studies and are not yet comprehensive”, and urged Chiesi to conduct an additional study to address these concerns.
The Committee for Medicinal Products for Human Use (CHMP) also gave Orexigen Therapeutics, an Irish pharma company, a positive opinion for Mysimba (naltrexone/bupropion).
The weight management tablet is recommended in adults who are obese, or who are overweight and have weight-related complications, and for use in addition to diet and exercise.
Michael Narachi, Orexigen chief executive, says: “With both the US approval and this positive endorsement by the CHMP, we will advance our plans for partnership and commercialisation of Contrave and Mysimba across the globe.”
Nicholas Finer, honorary professor at the University College London Institute of Cardiovascular Science, ays: “New treatment options are sorely needed in Europe, where there is currently only one prescription drug available for weight management.”
CHMP opinions:
- Zambon: Xadago (safinamide) received a positive opinion for the treatment of Parkinson’s disease.
- Durata therapeutics: Xydalba (dalbavancin) received a positive opinion for the treatment of skin and skin structure infections.
- Aptalis: Quinsair (levofloxacin) has been recommended for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.
- Genzyme: Tasermity (sevelamer hydrochloride) granted a positive opinion for informed consent application for the control of hyperphosphataemia in adults receiving dialysis.
- Generic Clopidogrel ratiopharm (clopidogrel): received a positive opinion for the prevention of myocardial infarction, ischaemic stroke, peripheral arterial disease and acute coronary syndrome, as well as the prevention of atherothrombotic and thromboembolic events in atrial fibrillation.
- Four recommendations on extensions of therapeutic indications: Revlimid (Celgene), Tresiba (Novo Nordisk), Velcade (Janssen-Cilag) and Xiapex (Swedish Orphan Biovitrum).
Lilian Anekwe
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