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Exclusivity GAINs Additional Indications: Advantages of QIDP Designation Paired with 505(b)(2) Strategy

Additional Indications: Advantages of QIDP Designation

The benefits of early strategy for 505(b)(2) drug development programs are numerous, but none as substantial as market exclusivity. Incentives available to sponsors of QIDP include fast track designation, priority review designation, and 5 years of additional market exclusivity.

A recently updated FDA guidance for U.S. antibiotic and antifungal development extends incentives to drugs that prevent or diagnose infections. This allows the expansion of a Qualified Infectious Disease Product (QIDP) designation to include multiple indications for one product, therefore permitting QIDP incentives for each indication. These types of incentives require careful early planning but position a product for maximum benefits once approved.

The Case for QIDP

As mentioned in a recent blog, Premier Consulting assisted Calla Therapeutics, LLC, in obtaining QIDP designation for MT-001, the company’s innovative vaginal cream drug candidate for the treatment of recurrent vulvovaginitis (RVVC). MT-001 is a 505(b)(2) drug candidate. RVVC is a serious condition caused by a pathogen, Candida species, that is a ‘‘qualifying pathogen’’ that has the potential to pose a serious threat to public health, under section 505E(f) of the FD&C Act (further specified in 21 CFR § 317.2, 2017). There are currently no approved therapies in the United States for RVVC. The local administration of MT-001 offers the application of the drug to the site of infection, where it’s needed while limiting the amount of drug that gets into the systemic circulation which drive the safety and tolerability concerns. Data were available in the published literature that support the premise.

Title VIII of FDASIA, Generating Antibiotic Incentives Now (GAIN), added section 505E of the Food, Drug & Cosmetic Act, providing incentives for the development of antibacterial and antifungal drugs for human use intended to treat serious and life-threatening infections (21 CFR § 317.2, 2017). To counter the threat of antibiotic resistance, the Act provides incentives and additional guidance to pharmaceutical companies developing innovative antibiotic products. Innovative includes both 505(b)1) as well as 505(b)(2) drug candidates. Incentives available to sponsors of QIDP include fast track designation, priority review designation, and 5 years of additional market exclusivity.

The Updates to QIDP

Although law (21 CFR § 317.2, 2017) defines QIDP as antibacterials and antifungals intended to treat serious infections, the FDA now interprets the provision more broadly to include preventive and diagnostic products, as stated in a new FDA draft guidance document (published January 2018). Antibacterial and antifungal drugs intended to prevent or diagnose a serious or life-threatening infection are also eligible for designation as a QIDP. The FDA interprets the phrase “intended to treat a serious or life-threatening infection” in the context of QIDPs in a similar manner to other programs under the FD&C Act. These programs are intended to expedite the development of drugs and biologics to address unmet medical needs. Accordingly, the FDA will consider a drug to be “intended to treat a serious or life-threatening infection” if it is intended to “diagnose, prevent, or treat such an infection.”

Importantly, as the QIDP designation applies to a specific drug product for a specific use for which it is being studied, one drug may receive more than one QIDP designation (e.g., one for treatment and one to prevent or diagnose).

Multiple QIDP Indications

That is exactly what Premier Consulting did for our client Calla Therapeutics, LLC. Calla received notification on Friday, March 30, 2018, that the FDA has granted a second QIDP designation to MT-001, to reduce the recurrence of vulvovaginitis. Premier Consulting previously assisted Calla Therapeutics, LLC. in its pursuit of QIDP designation for MT-001, for the treatment of RVVC.

Premier Consulting provided the innovative strategy and regulatory knowledge regarding the requirements and criteria that needed to be met in order to obtain two QIDP designations. As a result, Calla will be positioned to reap the benefits of QIDP designation with not only the additional 5 years marketing exclusivity but also increased communication with the FDA and expedited review of QIDP-designated drug application.

Identify the Incentives

If you have an already approved API (505(b)(2) antibacterial and antifungal drug candidate) to treat or prevent or diagnose a serious condition and address an unmet medical need, multiple QIDP designations may be attainable. Premier Consulting is ready to assist you in the pursuit of exclusivity incentives with our drug development knowledge, exhaustive use of data in the published literature, and innovative strategies.

To learn more about incentive opportunities for your program, contact us.


Stacey Ayres, PhD
Senior Director, Scientific and Regulatory Affairs