Merck’s Allergy Immunotherapy Suffers Review Delay Under Gov’t Shutdown
This article was originally published in The Pink Sheet Daily
Executive Summary
Without user fee coverage, advisory committees for Merck and Stallergenes’ new era grass allergy products must be pushed back from their scheduled November dates.
FDA has postponed two early November advisory committee meetings for grass allergy immunotherapies from Merck & Co. Inc. and Stallergenes SA because the products are not covered by prescription drug user fees, forcing work on their BLAs to halt during the government shutdown.
The two biological drug products – Merck’s MK-7243, a Timothy Grass Pollen extract tablet; and Stallergenes’ Oralair, a Sweet Vernal Grass, Perennial Ryegrass, Timothy Grass, Orchard Grass and Kentucky Bluegrass Mixed Pollens Allergen Extract tablet – are the first of a new type of oral allergy immunotherapies that could prevent allergic reactions instead of treating the symptoms.
Despite this novel treatment approach, FDA is reviewing the products under an older regulatory process traditionally used for injectable allergenic extracts (Also see "In Short Order, Merck And Stallergenes File BLAs For New Allergy Immunotherapies" - Pink Sheet, 19 Feb, 2013.).
Allergenic extract products, regulated by the Center for Biologic Evaluations and Research, are not within the scope of the Prescription Drug User Fee Act. As such, carryover user fee funding is not available for FDA to work on these BLAs, according to a FDA notice
for industry on its medical product activities during the federal shutdown.
“Due to the lapse period, FDA will not perform any activities with respect to these products except for emergency work involving the safety of human life or the protection of property,” the agency said of allergenic extract products and other biological products not covered by user fees, including whole blood and blood components for transfusion.
In contrast, scheduled advisory committee meetings that concern the approval or safety of specific medical products covered by PDUFA, the Generic Drugs Use Fee Act or Medical Devices User Fee Act programs are expected to take place during the shutdown, subject to constraints on resources or travel, FDA said (Also see "FDA In Twilight: Gov’t Shutdown Has Not Slowed Rx Operations Too Visibly Yet" - Pink Sheet, 7 Oct, 2013.).
Merck’s partner, ALK-Abello AS , and Stallergenes both announced the postponed Nov. 5 and 6 Allergenic Products Advisory Committee meetings Oct. 8, more than a week into the government shutdown. The agency has not confirmed new dates for the meetings and it would not comment on how the postponed meetings would affect when it would issue a decision on the drugs’ approvals.
A CBER official, who is furloughed but worked on Oct. 8 to help communicate the news of the postponed meetings, explained that the division overseeing the allergy immunotherapies’ reviews – the Division of Bacterial, Parasitic and Allergenic Products, which is part of CBER’s Office of Vaccines Research and Review – cannot work during the government shutdown.
Prior to news of the advisory committee postponement, Merck said it had anticipated FDA’s review of the BLA would be completed in the first half of 2014. The company would not speculate on the impact of the advisory committee postponement on approval.
ALK-Abello already markets MK-7243 in Europe as Grazax. Oralair has been available in the EU since March 2008 and is also available in Australia, New Zealand, Russia and Canada.
Merck’s oral immunotherapy for ragweed pollen, MK-3641, is also under FDA review. The company isn’t the only big pharma active in this new arena. Sanofi signed a deal with Selecta Biosciences Inc. in November 2012 to discover and develop three immunotherapies for food-based allergies (Also see "Sanofi And Selecta To Partner On Immunotherapies For Life-Threatening Allergies" - Pink Sheet, 28 Nov, 2012.).