Merck, GSK, BIO and Pew Comment on Draft Guidance on LPAD Approval Pathway
Merck, GlaxoSmithKline, BIO and Pew Charitable Trusts weighed in on recent draft guidance on the establishment of a limited population pathway for antibacterial and antifungal drugs (LPAD pathway).The draft is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway, which was created under the 21st Century Cures Act.
FDA says it will accept greater uncertainty and higher risk for products that qualify for the pathway, and that "drugs with risks that would be unacceptable for a broader population" may be acceptable for serious infections in limited patient populations when there is an unmet need.
Comments
Merck said that while it appreciates the two examples of drugs for which approval under the LPAD pathway could be appropriate, “given that several antibacterial drugs developed under streamlined clinical programs described in the Unmet Medical Need Guidance have been approved with ‘limited use’ labeling, we ask that the Agency provide additional examples of products appropriate for LPAD to further clarify their current thinking. Examples that help identify products for which the LPAD approval pathway might be valuable or necessary would be particularly helpful.”
Merck also seeks additional guidance on how to convey the limited population for which the drug is indicated and the drugs’ benefits and risks in promotional materials to “build consistency across products, and foster a common understanding regarding this special pathway for both patients and health care providers.”
In addition to offering specific recommendations, GSK sought more information on the requirements to lift LPAD and obtain full approval, asking, “How many studies or what data is/are needed in a supplement?”
GSK also questioned whether FDA wants to comment on whether drugs approved through this process are suitable for direct-to-consumer advertising.
Pew, meanwhile, notes that the Cures Act requires the collection of antimicrobial drug use and resistance trends, including those approved under the LPAD pathway.
“Additional language should be included in the finalized guidance on how FDA proposes to monitor the use of the LPAD-designated drugs and whether the limited population indication is working as intended or whether the drugs are being used in the broader population for whom they have not been evaluated,” Pew said.
Industry group BIO also encourages FDA to be open to exploring "any and all options to bring these products to patients through scientifically justified trial designs that demonstrate an acceptable benefit/risk profile for these high-risk populations with unmet needs."
Comments