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FDA Breakthrough Therapy Designation: Approval For Gilead Sciences’ HCV Combo Drug

October 10, 2014

On October 10th, the FDA approves Gilead Sciences’ Combo Drug, Harvoni (Ledipasvir 90 mg/Sofosbuvir 400mg), for Genotype 1 Chronic Hepatitis C (HCV). Harvoni is the first once-daily single tablet regimen and first all-oral regimen for the treatment of Genotype 1 Chronic HCV.

Harvoni receives FDA Breakthrough Therapy Designation (BTD) and Priority Review. The drug is a combination of the NS5A inhibitor Ledipasvir with the nucleotide analog polymerase inhibitor Sofosbuvir. Sofosbuvir (Sovaldi) receives the FDA BTD and FDA approval in December 2013 as a monotherapy for HCV.

Harvoni’s approval is based on three Phase III studies (ION-1, ION-2, and ION-3). The primary endpoint for each study was Sustained Virologic Response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients are considered cured of HCV if they achieve SVR12. Harvoni achieved SVR12 of 94 – 99% in all three Phase III studies. The drug also shortens treatment duration to just eight weeks for certain treatment-naïve patients and eliminates the need for Interferon and Ribavirin for patients with Genotype 1 Hepatitis C.

Since its approval, Sovaldi has gained media attention because of its high cost. According to the New York Times :

•   Sovaldi costs $1,000/pill or $84,000/12-week course of treatment ; must be used with other drugs

•   Harvoni costs $1,125/pill or $94,500/12-week course of treatment ; other drugs not required

•   Harvoni costs $63,000/8-week course of treatment which many patients will be able to do.

Nezam Afdhal, MD, Director of Hepatology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and a principal investigator in the Harvoni clinical trials says that:

“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States. For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks.”

This is the 3rd FDA BTD to receive approval for Gilead Sciences:

FDA BTDs Receiving Approval For Gilead Sciences

Drug Name FDA Approval Date Indication
Sovaldi   (Sofosbuvir) 12.06.13 Hepatitis C
Zydelig (Idelalisib) 07.23.14 Chronic Lymphocytic Leukemia (CLL)
Harvoni (Ledipasvir /Sofosbuvir) 10.10.14 Genotype 1 Chronic HCV




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Harvoni photograph courtesy of Gilead Sciences.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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