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A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy

In an era of pandemic urgency, repurposed drugs may be our first, best hope to finding effective treatments for COVID-19. Dozens of sponsors are now seeking efficient, streamlined processes to test and establish the safety and efficacy of existing products for the treatment of the novel coronavirus.

Even before the emergence of SARS-CoV-2, the 505(b)(2) regulatory pathway had been growing in popularity. Novel treatments based on known active ingredients can be approved and brought to market more quickly and economically when a bridge is established from a previously approved drug to a new indication or product. When successful, the 505(b)(2) pathway enables sponsors to realize significant cost savings and timeline efficiencies while often preserving exclusivity benefits.

The 505(b)(2) pathway requires full safety and efficacy data to be included in the NDA package, but the data can come from a diverse range of sources (i.e., not just studies conducted by the sponsor). This is the challenge of using the 505(b)(2) pathway – the variability in required submission resources, customized specifically to your development program. Because 505(b)(2) is a hybrid process, there is no single regulatory strategy or definitive checklist a sponsor can follow. It requires professionals with knowledge of this specialized pathway, its nuanced regulatory considerations, and how to successfully bridge to various sources of information. Having this expertise as part of your development team is key to communicate effectively with stakeholders and shepherd a product through every stage of the process.

What Is 505(b)(2)? What Is It Not?

The 505(b)(2) pathway exists for treatments in a spectrum between novel products requiring a 505(b)(1) NDA, the full approval application using the sponsor’s data collected through regulated clinical trials, and those requiring a 505(j) ANDA, the regulatory process intended for generic products where “sameness” must be established.

Products suitable for the 505(b)(2) pathway contain active ingredients that have already been well documented and may be present in previously approved drug products. The new product under consideration may be an existing drug in a new dosage format with a more favorable method of administration. The novel product may be a faster acting version of an existing treatment or it may be a new way of combining active ingredients. As we work to address COVID-19, we’ve seen examples of an old product repurposed for the treatment of a new disease or condition. The 505(b)(2) pathway may also be used by sponsors to seek approval to use a previously approved product for a new indication or to change a drug’s status from prescription to over-the-counter.

Partner with Premier Consulting for Strategy and Regulatory

Navigate the complexities of the 505(b)(2) development pathway with an experienced partner who can help your program succeed. Premier Consulting’s team of scientists and drug development experts specialize in complex development programs that require a customized approach to regulatory and development strategy. Contact Premier Consulting to learn more about our strategy and regulatory solutions.