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

Regulatory, Clinical Research
505(b)(2) team

This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. It was co-written by the Editors at Uncommon Conversations and the experts at Camargo.

505(b)(2) team

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.

A 505(b)(2) Primer

A recent Uncommon Conversations webinar explores the important considerations sponsors should take into account when contemplating a 505(b)(2) pathway for approval of their novel therapy. It features experts Sherilyn Adcock, Executive Vice President of Medical and Scientific Affairs at Worldwide Clinical Trials, as well as Kristi Norris, Director of Regulatory Strategy at Camargo Pharmaceutical Services. Dr. Norris partners with sponsor companies to navigate complex development programs that require a customized approach to regulatory and development strategy, like the 505(b)(2) pathway.

Topics covered in the webinar include

  • an overview of the 505(b)(2) regulatory pathway,
  • the changing landscape and growing popularity of the 505(b)(2) pathway,
  • regulatory implications around 505(b)(2) submissions,
  • recommendations for sponsors considering the 505(b)(2) pathway, and
  • pitfalls to avoid.

As Dr. Adcock says, “There is no simple guidance . . . that provides a clear path for 505(b)(2) approvals. But that does not mean this approach should be avoided. There are too many benefits to be gained by pursuing this approach.” If you think your product might be a fit for this hybrid regulatory approach, or even if you’re not sure, our webinar provides a primer that will help you evaluate the 505(b)(2) pathway as an option for your proposed drug.

Ready to try 505(b)(2) on for size? Watch the webinar now.

Partner with Camargo for Strategy and Regulatory

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

Trust Worldwide Clinical Trials for Quality Data

When your 505(b)(2) strategy calls for new Phase I data, Worldwide has the expertise and facilities to design and execute your clinical trials. Our dedicated clinical pharmacology unit and bioanalytical lab have set industry standards for services, staff, and accessibility. Our professionals are personally committed to the success of our clients, irrespective of size, whatever the scope of the project.  

Talk to a Worldwide expert today to learn more about how we can support your 505(b)(2) submission.

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