David takes on Goliath: AbbVie to disrupt Gilead’s dominance

Pharmaceutical Technology

David takes on Goliath: AbbVie to disrupt Gilead’s dominance
Jan 5
On December 8 and December 19, 2016, Gilead Sciences and AbbVie, respectively, filed new drug applications (NDAs) with the FDA for their novel pan-genotypic direct acting antiviral (DAA) regimens against the hepatitis C virus (HCV).

With both regimens having received Breakthrough Therapy designation, GlobalData expects the FDA to deliver a positive verdict for each drug combination during the third quarter of 2017. Despite this apparent head-to-head competition for market access, once approved, AbbVie’s 2-DAA regimen is poised to successfully challenge both of Gilead’s newest pipeline products as well as their recently approved Epclusa (sofosbuvir + velpatasvir), the first pan-genotypic DAA regimen launched in the US.

Recently published clinical data indicate that AbbVie’s DAA regimen, consisting of glecaprevir + pibrentasvir (G/P), not only provides an excellent efficacy.....
Continue reading.....

Related
Seeking Alpha
Can AbbVie Make A Mark In The Virology Segment In 2017?
Jan 6
While immunology and oncology are the key focus areas for AbbVie (NYSE:ABBV), the company also believes in the growth potential of the hepatitis C or HCV ...

Why Gilead Sciences Lost a Staggering 29.2% In 2016
By Todd Campbell Published January 05, 2017
Gilead Sciences remains the hepatitis C market share leader, and next-generation hepatitis C drugs, including Epclusa, may help shore up sales this year. The company's also enjoying growing demand for its HIV drugs, which has been refreshed by the launch of combination therapies that include TAF, a safer formulation of the long-standing HIV drug Viread.

AbbVie Awaits NDA Approval For Hepatitis C Treatment
Dec. 19, 2016
AbbVie (ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV).

Gilead Submits NDA to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir HCV Genotype 1-6
December 8, 2016
Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available as a Salvage Therapy for Patients Infected with HCV Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors -