Vertex Pharmaceuticals announced today that the FDA has
accepted the New Drug Application (NDA) for telaprevir and granted the
company’s request for six-month Priority Review. Telaprevir is Vertex’s lead
medicine in development for people with genotype 1 chronic hepatitis C. The FDA
grants Priority Review to medicines that offer major advances in treatment or
provide a treatment where no adequate therapy exists. A target review date of May
23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA’s
approval decision, which is four months earlier than the standard review time
of 10 months.
Additionally, Vertex today announced the completion of a New
Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada.
Telaprevir was also granted Priority Review in Canada, which allows for faster
review for promising medicines that address life-threatening or severely
debilitating conditions and for which there are few effective therapies already
available. Standard review in Canada
takes 18 months or more and Priority Review typically shortens the review time
to approximately six to nine months.
In December 2010, Janssen-Cilag International NV announced
that the European Medicines Agency (EMA) accepted telaprevir for accelerated
assessment in Europe, which is granted to new
medicines of major public health interest.
“Data from Phase 3 studies showed that when compared to
currently available medicines, telaprevir-based combination therapy nearly
doubled viral cure rates and cut treatment time in half for the majority of
patients new to treatment,” said Peter Mueller, Ph.D., Chief Scientific
Officer and Executive Vice President of Global Research and Development at
Vertex. “We look forward to working with the FDA and Health Canada to make
telaprevir available as quickly as possible for people with hepatitis C.”
