29 Aralık 2014
AB'de ilk kök hücre tedavisi onayı..
EU body recommends approval of first stem-cell therapy from Chiesi
(Ref: BBC News, Business Insider, EMA, The Telegraph)
December 19th, 2014
By: Joe Barber
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday backed approval of Chiesi's Holoclar for the treatment of moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye in adults. The regulator noted that Holoclar is "the first advanced therapy medicinal product containing stem cells" recommended for clearance in the EU, as well as being the first medicine recommended for LSCD.
The CHMP's decision was based on an assessment conducted by the EMA's Committee for Advanced Therapies (CAT), with both committees recommending a conditional marketing authorisation for Holoclar because the data provided by Chiesi were based on retrospective analyses. The EMA indicated that an additional study of the therapy should be conducted.
Enrica Alteri, head of the EMAs Human Medicines Evaluation Division, commented that the recommendation by the CHMP "represents a major step forward in delivering new and innovative medicines to patients." The agency described Holoclar as "a living tissue equivalent intended to be transplanted in the affected eye(s) after removal of the altered corneal epithelium." The regulator added that the treatment is created from a biopsy obtained from a small healthy area in the patient's cornea and grown in the laboratory using tissue culture techniques.