FDA Grants Sofosbuvir Breakthrough Therapy Designation


Sofosbuvir 1190307-88-0 Breakthrough Therapy StatusThe end of October 2013 saw a nod from the FDA given to Gilead’s New Drug Application for Sofosbuvir. As a greatly needed treatment for hepatitis C Sofosbuvir has proven to be effectual and tolerable in a number of studies. Sofosbuvir is marketed by Gilead Science, Inc. and is clearly set up for success in the pharmaceutical arena. With roughly 170 million cases of hepatitis C around the world, the Sofosbuvir breakthrough therapy designation is crucial to fulfill the need for novel and effective treatments. The expanding patient population in the United States infected with chronic cases of hepatitis C hovers around 4 million people. Additionally, there are a substantial number of new patients diagnosed with hepatitis C each year in the U.S., with almost 30,000 new American diagnoses each year. The Advisory Committee of the FDA clearly supported Gilead’s Sofosbuvir with a unanimous vote of support, granting Sofosbuvir breakthrough therapy designation status. The FDA committee also unanimously recommended the approval of Sofosbuvir in conjunction with Ribavirin and Pegylated Interferon for treatment naïve patients with chronic hepatitis C who have the specific genotype 1 and genotype 4 infections.

As a nucleotide analogue, Sofosbuvir is designed as a once daily treatment which has demonstrated safe and formidable effects fighting the hepatitis C virus. Studies included four Phase 3 trials coined FISSION, FUSION, NEUTRINO and POSITRON. The POSITRON study specifically showcased the benefits of Sofosbuvir in patients who were unable or unwilling to take adjunctive interferon. Patients with genotypes 1 and 4 hepatitis C infections will still need to be treated with peg interferon, but the concomitant use of Sofosbuvir makes a shorter treatment time available, specifically 12 weeks duration, creating a lesser probability of adverse effects. Patients with the hepatitis genotype 3 infections displayed success in the FUSION trial after a full 16 weeks of treatment with Sofosbuvir. While a 12 week course of treatment did reveal positive data, the percentage of genotype 3 patients finding relief grew substantially with the extended course of treatment.

The FDA is looking at a possible approval of Sofosbuvir in early December 2013. LGM Pharma provides the Sofosbuvir CAS# 1190307-88-0 API for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

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  • FDA announces approval of Gilead's once-a-day pill Sofosbuvir
    Posted on January 2, 2014 at 9:32 pm

    […] committee awarded Gilead breakthrough therapy status for Sofosbuvir at the end of October 2013 (see previous Sofosbuvir article). The FDA committee also unanimously recommended the approval of Sofosbuvir in conjunction with […]

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