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2014-07-15

Medivir: U.S. FDA has granted Priority Review for OLYSIO® in combination with sofosbuvir supplementary New Drug Application

Stockholm, Sweden - Medivir AB (OMX: MVIR) announces that the Food and
Drug Administration (FDA) has assigned a Priority Review designation
to the supplemental New Drug Application (sNDA) for the use of
once-daily Olysio (simeprevir) in combination with sofosbuvir for 12
weeks treatment of adult patients with genotype 1 chronic hepatitis
C. The sNDA was filed in May by Medivir's strategic partner Janssen
Research & Development LLC.

The regulatory submission for Olysio and sofosbuvir is supported by
data from the phase II COSMOS study which included treatment-naïve
patients with advanced fibrosis (METAVIR F3 to F4 scores) and prior
null-responder patients with all stages of liver fibrosis (METAVIR F0
to F4 scores).

"The Priority Review designation by the FDA shows the high priority
and great importance of making interferon-free treatment regiments
available to the many difficult to cure hepatitis C patients groups",
says Charlotte Edenius, EVP Development, Medivir.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

About Olysio®
Olysio is an NS3/4A protease inhibitor jointly developed by Janssen
R&D Ireland and Medivir AB and indicated for the treatment chronic
hepatitis C infection in combination with pegylated interferon and
ribavirin in HCV genotype 1 and 4 infected patients with compensated
liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of Olysio
and has exclusive, worldwide marketing rights, except in the Nordic
countries. Medivir AB retains marketing rights for Olysio in these
countries under the marketing authorization held by Janssen-Cilag
International NV. Olysio was approved for the treatment of chronic
hepatitis C infection as part of an antiviral treatment regimen in
combination with pegylated interferon and ribavirin in genotype 1
infected adults with compensated liver disease, including cirrhosis
in September 2013 in Japan, in November 2013 in Canada and the U.S.
and in March 2014 in Russia. Following the EMA approval, it is
anticipated that Olysio will be available across a number of European
Union countries in conjunction with reimbursement, in the second half
of 2014.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused
on infectious diseases. Medivir has world class expertise in
polymerase and protease drug targets and drug development which has
resulted in a strong infectious disease R&D portfolio. The Company's
key pipeline asset is Olysio, a novel protease inhibitor for the
treatment of hepatitis C that is being developed in collaboration
with Janssen R&D Ireland. The company is also working with research
and development in other areas, such as bone disorders and
neuropathic pain. Medivir has also a broad product portfolio with
prescription pharmaceuticals in the Nordics.

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http://news.cision.com/medivir/r/u-s--fda-has-granted-priority-review-fo...
http://mb.cision.com/Main/652/9616973/267080.pdf

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