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Epclusa Approval History

  • FDA approved: Yes (First approved June 28th, 2016)
  • Brand name: Epclusa
  • Generic name: sofosbuvir and velpatasvir
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: Hepatitis C

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

The safety and efficacy of Epclusa was evaluated in three Phase 3 studies (ASTRAL-1, ASTRAL-2 and ASTRAL-3) of 1,558 patients without cirrhosis or with mild cirrhosis. Of the 1,035 patients who received Epclusa for 12 weeks, 98 percent had no virus detected in their blood 12 weeks after finishing treatment. The safety and efficacy of Epclusa was also evaluated in the Phase 3 ASTRAL-4 study of 267 patients with moderate to severe cirrhosis. Of the 87 patients who received Epclusa in combination with ribavirin for 12 weeks, 94 percent had no virus detected in the blood 12 weeks after finishing treatment.

Epclusa is a tablet taken orally once daily with or without food for 12 weeks. Patients with moderate to severe cirrhosis will need to take Epclusa in combination with ribavirin. The most common side effects of Epclusa include headache and tiredness.

Development History and FDA Approval Process for Epclusa

Jun 28, 2016Approval FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection
Jan  4, 2016Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection
Oct 28, 2015Gilead Submits NDA to U.S. FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

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