**Gilead Submits NDA for Hepatitis C Drug Sofosbuvir**
Foster City, Calif., April 8, 2013 — Gilead Sciences has submitted a New Drug Application (NDA) to the U.S. FDA for sofosbuvir, an innovative once-daily oral treatment for chronic hepatitis C infection. This marks a significant milestone, as sofosbuvir could potentially transform the hepatitis C treatment landscape due to its efficacy and simplicity of dosing.
Sofosbuvir, a nucleotide analog polymerase inhibitor, demonstrates high efficacy, achieving sustained virologic response rates across several phase 3 clinical trials. These trials involved diverse patient populations, including treatment-naïve and those previously treated with hepatitis C virus (HCV) genotype 1, 2, or 3. The NDA submission follows promising trial results, including a reduction in treatment duration and a favorable safety profile.
The submission underscores Gilead’s commitment to advancing simplified therapeutic regimens in HCV treatment, potentially leading to shorter, more effective therapies. Investors should note the potential for sofosbuvir to capture significant market share, given its strong efficacy and convenience over existing therapies, should it receive FDA approval.
For those following biotech investments, FDA approval can significantly influence a company’s market valuation. The regulatory decision for sofosbuvir will be critical for Gilead and may set a precedent for future nucleotide analogs in antivirals.
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