ACH-1625 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C
Fast Track designation was granted to ACH-1625 for its potential to provide:
- Improved safety and tolerability as compared to the current standard of care;
- Convenient once-daily dosing;
- Broader genotypic coverage of HCV;
- An improved drug-drug interaction profile with greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre- or post-liver transplantation; and
- Development in a once-daily interferon-free oral combination.
"We are very pleased with the granting of a Fast Track designation for ACH-1625, which we believe highlights this protease inhibitor's attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," commented Michael Kishbauch, President and Chief Executive Officer of Achillion. "As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year."
Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment of serious or life-threatening diseases which demonstrate the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file an NDA on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which could decrease the typical development time and review period.