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 The Dutch company said it had received a final assessment report
from the European Medicines Agency's Committee for Advanced
Therapies (CAT) following doubts raised by the adviser, a so-called
rapporteur.
"The CAT did not agree with the negative view of the rapporteur,"
UniQure said in a statement, adding that the views of the CAT were
endorsed by the agency's senior body, the Committee for Human
Medicinal Products.
UniQure's Nasdaq-listed shares fell last month when it emerged that
the rapporteur believed Glybera lacked efficacy. A German regulator
for new drugs also suspended its assessment of the product.
The drug, which is sold by UniQure's unlisted Italian marketing
partner Chiesi for treating an ultra-rare blood disorder, has had a
tortuous journey to market as regulators have struggled to assess
its effectiveness because of the very small number of patients
available for clinical tests.
The medicine was approved in Europe two years ago but its launch was
delayed to allow for the collection of six-year follow-up data on
its benefits.
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UniQure is also developing other gene therapies that are viewed as
more important to its commercial future. In April it signed a major
collaboration deal with Bristol-Myers Squibb.
(Reporting by Ben Hirschler; editing by Jason Neely)
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