Adam Feurestein Reminds Twitter Followers 'Today Is Merck's HepC elbasvir/grazoprevir PDUFA'

The Street's biotechnology and drug stock expert, Adam Feuerstein, reminded his Twitter followers of an important event with the healthcare space.

On November 14, 2015,

Phase 3 results of an invitational Elbasvir/Grazoprevir in People with Chronic Hepatitis C Genotypes 1, 4 or 6 Infection Who Inject Drugs and Are on Opioid Agonist Therapy. Elbasvir/grazoprevir is Merck's investigational, once-daily, fixed-dose combination therapy containing elbasvir and grazoprevir. Merck stated that 95 percent of patients who were treated with elbasvir/grazoprevir for 12 weeks in the pre-specified primary efficacy analysis population achieved sustained virologic response 12 weeks after the completion of treatment. "Injection drug use is a major factor fueling the global hepatitis C crisis, yet people with chronic hepatitis C virus infection who inject drugs often remain overlooked and underserved," Dr. Ronald Nahass, president, ID CARE, New Jersey said on November 14. "Patients in this study with chronic hepatitis C virus infection on opioid agonist therapy, including many who continued to use drugs during the trial, were able to complete treatment with elbasvir/grazoprevir and achieve high virologic cure rates." The FDA granted a Breakthrough Designation for elbasvir/grazoprevi in April 2015. In July, the FDA granted Priority Review for the New Drug Application with a Prescription Drug User Fee Act (PDUFA) action date scheduled for January 28.