Hepatitis C Drug TMC435 Gets Fast Tracked
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Medivir: TMC435 has Received Fast Track Designation from the FDA and TMC435 will be studied in combination with Pharmasset’s PSI-7977 for HCV genotype-1
HUDDINGE, Sweden, Jul 06, 2011 (BUSINESS WIRE) — Regulatory News:
Medivir AB (sto:MVIRB)(omx:MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases.
Medivir today announced that its investigational protease inhibitor TMC435 has received “Fast Track” designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435’s potential to address unmet medical needs in the treatment of CHC infection compared to currently approved therapies.
TMC435 may offer:
- High sustained virological response (SVR) rates in genotype-1 HCV-infected patients, including hard-to-treat subgroups
- Short treatment duration
- Favorable overall safety and tolerability profile
- A convenient once-daily (q.d.) dosing regimen
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http://www.marketwatch.com/story/medivir-tmc435-has-received-fast-track-designation-from-the-fda-and-tmc435-will-be-studied-in-combination-with-pharmassets-psi-7977-for-hcv-genotype-1-2011-07-06?reflink=MW_news_stmp
