Nanjing, China, Nov 7th, 2019 - Frontier Biotechnologies, Inc. (Frontier Biotech) announced that US Food and Drug Administration (USFDA) has granted the Fast Track designation (FTD) to its all-injectable anti-HIV two-drug combination of 3BNC117 and Aikening® for the treatment of multidrug-resistant (MDR) HIV-1 infection.
3BNC117 is one of the most advanced anti-HIV broadly neutralizing antibodies (bNAb) under clinical development worldwide. Several Phase I and Phase II clinical trials have been conducted in the United States and demonstrate that 3BNC117 not only effectively suppresses HIV virus replication, but also elicits host immune responses against HIV virus and infected cells. Aikening® (Albuvirtide for injection) is a Class 1 new drug that is solely developed by Frontier Biotech and has received marketing authorization from NMPA (The National Medical Products Administration, formerly known as CFDA) in May, 2018. Aikening® has a novel mechanism of action and is effective against epidemic and resistant HIV-1 virus, as well as the advantages of lower dosing frequency (once a week), higher barrier to resistance, superior safety profile and less side effects. Frontier Biotech is developing the combination of Aikening® and 3BNC117 as an all-injectable, long-acting, two-drug regimen with novel mechanisms of action, aiming to supplement and/or replace the oral-only antiretroviral therapy (ART) regimens, as well as achieve drug-free sustained viral remission through antibody-mediated immunotherapy.
Fast track* is a designation by the USFDA of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. An investigational drug that receives FTD is eligible for some or all of the following:
l More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
l More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
l Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
l Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
*More information can be found at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.