Daclatasvir Awarded FDA Breakthrough Therapy Designation


DaclatasvirDaclatasvir has been in the pharmaceutical spotlight lately as part of a new hepatitis C cocktail. Bristol-Myers Squibb revealed their achievement of a breakthrough drug designation from the FDA for the Daclatasvir based combination hepatitis C treatment. The FDA’s decision to grant a breakthrough designation for this oral drug combination of Daclatasvir and Asunaprevir is exciting for the swath of patients affected by genotype 1b hepatitis C.  As an NS5A replication inhibitor Daclatasvir is a successful counterpart to this novel treatment drug duo. Sales projections for Bristol-Myers Squibb have been extraordinary based on this breakthrough designation, with analysts predicting close to a six billion dollar profit by the end of 2014. Should these projections come to pass this would be a landmark event for the makers of this Daclatasvir based drug combo, making it a historically significant drug launch for the United States.

Progression of Hepatitis CA staggering 170 million patients are suffering from hepatitis C worldwide, with almost 4 million of these patients being in the United States. As this life threatening disease poses many health complications for patients, the majority of patients with hepatitis C will endure debilitating liver disease. The advent of Bristol-Myers Squibb’s Daclatasvir combination treatment provides a new hope for this sizable patient population.

Results were encouraging from the dual therapy Daclatasvir and Asunaprevir study.  Approximately 18 patients with genotype 1b hepatitis C were administered this dynamic drug combination. A large portion of the patients, roughly 78 percent, or 14 people achieved a sustained virologic response  and were considered cured after just 12 weeks of Daclatasvir and Asunaprevir. The combo treatment of these two powerhouse drugs was dispensed orally to patients once daily. There were no patients who exhibited adverse effects causing them to withdraw from the study. The majority of side effects reported were mild and included weakness, diarrhea and headache.

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