Virtual Advisory Committees: Who Will Be First In Line To Test On-Line Meetings?

US FDA says it is preparing to hold ‘virtual’ advisory committee meetings amid the COVID-19 outbreak. Does anyone want to go first?

Who will be the first sponsor to take an application to a “virtual” advisory committee hosted by the US Food & Drug Administration?

While one can always hope that the COVID-19 outbreak recedes quickly enough that FDA will feel comfortable convening in person meetings again in the near future, it is far more likely that the next time a new drug application goes before one of FDA’s panels of outside experts, it will be a “virtual” event.

A “virtual” meeting will undoubtedly have different dynamics than a traditional advisory committee, and sponsors will no doubt be eager to learn as quickly as possible what new wrinkles they need to anticipate. That makes the prospect of going first feel daunting. (Also see "US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?" - Pink Sheet, 1 Apr, 2020.)

At this point, it is far from clear who will be the pioneer in virtual meetings. All new drug application reviews that had been announced for this spring have been cancelled by the agency, and as of April 29 no “virtual” meeting dates have been confirmed by FDA.

FDA has also provided an unusual update on one of the meetings impacted by to COVID, which sounds like good news for the sponsor: a proposed review of Eli Lilly & Co.’s “Tau Tracer” Alzheimer’s diagnostic will not be rescheduled, FDA says, because “the issues for which the Food and Drug Administration was seeking the scientific input of the Committee have been resolved.” (Also see "Keeping Track: US FDA Clears Oncologics Tukysa And Jelmyto; Regeneron Anti-Ebola Cocktail Under Review" - Pink Sheet, 19 Apr, 2020.)

FDA posted that update on 13 April; the 22 April meeting was originally “postponed” due to the COVID outbreak, implying that it might be rescheduled in virtual format. The 21 April committee review of GlaxoSmithKline PLC’s Trelegy inhaler for a potential COPD mortality claim, in contrast, is still described as “postponed.”

Another formally cancelled meeting – a planned May 15 review of DBV Technologies SA’s Viaskin Peanut allergy patch – was also explicitly not scrubbed solely due to COVID. Instead, FDA says it needs “time ... to review outstanding issues” and that it “will schedule an advisory committee meeting in the future, as needed.”

That leaves GSK and Trelegy as one potential candidate to go first in the virtual format. Another may be Intercept Pharmaceuticals Inc., which has disclosed a planned meeting date (June 9) for the potential first ever NASH indication for obeticholic acid (OCA, marketed as Ocaliva).

FDA has not confirmed that date, but Intercept has consistently cited an advisory committee as expected for the application – and had been preparing for a late April date until the COVID cancellations. (Also see "Delayed Advisory Committees Need Not Worry Sponsors Too Much" - Pink Sheet, 15 Apr, 2020.)

There are certainly plenty of other applications where an advisory committee appears likely if not certain – but most are likely to come later in the year. For example, Pfizer Inc. and Lilly have filed for approval of anti-NGF agent tanezumab, with a user fee goal date near year-end. Given the safety issues that have clouded the NGF class – as well as the overwhelming public health interest in non-opioid pain treatments – an advisory committee stop is expected, and FDA informed the sponsors on 2 March in accepting that filing that it would plan to convene one.

FDA is clearly not eager to start the “virtual” process with a difficult application. In a recent interview, Office of New Drugs Director Peter Stein noted that the agency is proceeding carefully to ensure that virtual meetings involve a relatively narrow set of questions with a focused panel. (Also see "Virtual Advisory Committees Are Coming: US FDA Panels Will Be Smaller, More Focused" - Pink Sheet, 15 Apr, 2020.)

Stein alluded to a planned meeting of an important public health topic with multiple committees that was specifically not going to be an early test of the “virtual” format. “We did have a meeting planned that had two different advisory committees coming together, and with a relatively complex set of issues that were quite diverse, and we canceled that,” Stein said. “First of all, it was something that we could cancel, because it was something that was important, but making sure it was a productive discussion was even more important,” Stein said.

He did not identify the specific topic, but those remarks suggest that the long-delayed consideration of a “Real World” abuse deterrent claim for Purdue Pharma LP’s OxyContin is unlikely to be done as a “virtual” event, at least until after the agency has ample experience with the format.

FDA officials disclosed during a review of Intellipharmaceutics International Inc.’s proposed abuse-deterrent oxycodone formulation on 15 January that Purdue’s “real-world” data for OxyContin had been submitted to the agency and would likely be taken to committee in the near future. (Also see "‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA" - Pink Sheet, 22 Jan, 2020.)

All of which implies that – as uncomfortable as it may be for a sponsor to try to prepare – being chosen to go first for a “socially distanced” panel is probably a good sign for the product involved. It might mean that an upcoming approval is “virtually” certain.