Sofosbuvir FDA approval

Every drug has to go through three phases of successful clinical trials in order to get a FDA approval to be used for treatment. Sofosbuvir was no exception. Sofosbuvir FDA approval was successfully obtained on 6th of December, 2013, by Gilead Sciences for the use in chronic Hepatitis C treatment. Gilead developed the drug named Sovaldi, based on Sofosbuvir which was discovered by Pharmasset – the pharmaceutical company Gilead acquired in 2011. Interestingly enough, Sofosbuvir was one of the two chronic Hepatitis C treatment medicines approved in the end of 2013. On 22th of November, 2013, simeprevir molecule was approved, used in the drug called Olysio by Medivir and Janssen. It is used for the treatment of Hepatitis C, predominantly genotype 1 Hepatitis C.

sofosbuvir fda approval

The road to Sofosbuvir FDA approval began on 8th of April, 2013 when Gilead submitted the Sovaldi's ‘New Drug Application' to the FDA (Food and Drug Administration). FDA, in turn, rewarded Sovaldi with a special status for a new-coming medicine – the Breakthrough Therapy Designation. This status is reserved for medicines that show major treatment advantages over the treatments that are currently accessible on the market. In the case of Sofosbuvir, the competing therapy is the interferon treatment of Hepatitis C, which is not all-oral, shows weaker cure rates and higher side effects. This designation meant that Sovaldi obtained priority review status – this is also the reason why it took only half a year for FDA to approve Sofosbuvir.

Sofosbuvir FDA approval consists of Sovaldi drug by Gilead treating various Hepatitis C infection. FDA approved Sovaldi for genotype 1, 2, 3 and 4 treatment. It also approved the treatment of patients waiting for liver transplant and those co-infected with HIV-1 virus. Here the immense advantages of Sofosbuvir are observed – FDA decided that the new drug can be used for people with severely damaged liver and also patients that have are suffering from AIDS that also have Hepatitis C.

There are certain precautions that need to be observed when treating with Sovaldi:

  1. Sovaldi (Sofosbuvir) is to be used in combination with other drugs (such as ribavirin, and sometimes interferon)
  2. Treatment regiment and the length of treatment are not the same for all patients – it depends on Hep C genotype and patient population
  3. The success of the Sofosbuvir treatment depends on the patient and the virus

The following regiments of Sovaldi was FDA approved: one Sovaldi pill containing 400 mg of Sofosbuvir per day, taken orally. It should be taken together with ribavirin and, if needed, interferon. Without the interferon, this is the first all-oral Hepatitis C treatment.

Here is how Hepatitis C is treated with Sovaldi:

Treatment Duration
Patients with genotype 1 or 4 CHC (chronic Hepatitis C)  SOVALDI + interferon + ribavirin 12 weeks
Patients with genotype 2 CHC  SOVALDI + ribavirin 12 weeks
Patients with genotype 3 CHC  SOVALDI + ribavirin 24 weeks


sofosbuvir fda approval

On another note, this Sofosbuvir FDA approval is not the only one Gilead means to bring to the table. On 10th of February, Gilead filed for FDA approval of Sofosbuvir pills with ledipasvir. This is what was stated in the application:

Ledipasvir/Sofosbuvir is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination in development for the treatment of chronic hepatitis C genotype 1 infection.

This is another good news for Hepatitis C patients all over the world. Starting with Sofosbuvir FDA approval, the doors were opened for medicines approval that contains Sofosbuvir in Europe and the rest of the world as well. For example, the next big thing is the registration in Europe where EMA (European Medicines Agency) has the same role as FDA in US.



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