VERY GOOD NEWS AND WHY $MNKD IS UP AFTER HOURS. No MORE REMS FOR AFREZZA and won't be needed for pediatric use once it is approved for it.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
NDA 022472/S-017
SUPPLEMENT APPROVAL
MannKind Corporation
Attention: Robyn Walsh, M.S.
Senior Manager, Regulatory Affairs
One Casper Street
Danbury, CT 06810
Dear Ms. Walsh:
Please refer to your supplemental New Drug Application (sNDA) dated and received
April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
(FDCA) for Afrezza (insulin human) inhalation powder.
This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk
evaluation and mitigation strategy (REMS). This supplement is in response to our
April 17, 2018, REMS Modification Notification letter.
We have completed our review of this supplemental application. It is approved effective on the
date of this letter.
RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
The REMS for Afrezza (insulin human) inhalation powder was originally approved on
June 27, 2014, and the most recent REMS modification was approved on April 20, 2015. The
REMS consists of a communication plan and a timetable for submission of assessments of the
REMS. In order to minimize burden on the healthcare delivery system of complying with the
REMS, we determined that you were required to make the REMS modifications outlined in our
REMS Modification Notification letter dated April 17, 2018.
Communication Plan: We have determined that the communication plan is no longer necessary
as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder
outweigh its risks because the communication plan has been completed and the most recent
assessment demonstrated that the communication plan has met its goals. No further assessments
are necessary to assess the current communication plan.
Therefore, because the communication plan is no longer necessary to ensure the benefits of the
drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation
powder.
Reference ID: 4252859
NDA 022472/S-017
Page 2
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients (which includes new salts and new fixed combinations), new indications, new
dosage forms, new dosing regimens, or new routes of administration are required to contain an
assessment of the safety and effectiveness of the product for the claimed indication in pediatric
patients unless this requirement is waived, deferred, or inapplicable.
Because none of these criteria apply to your supplemental application, you are exempt from this
requirement.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at
(240) 402-6149.
Sincerely,
{See appended electronic signature page}
Jennifer Rodriguez Pippins, M.D., M.P.H.
Deputy Director for Safety
Division of Metabolism and Endocrinology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research
Reference ID: 4252859
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This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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JENNIFER R PIPPINS
04/24/2018
Reference ID: 4252859
