RJ Health Systems Monthly Specialty FDA Actions (PDUFA Dates) Newsletter – January/February 2018 – Volume 1 – Number 1/2

2017 was a busy year for the Food and Drug Administration (FDA) with a 100 percent score in meeting the assigned (Prescription Drug User Fee Act) PDUFA dates for 46 products.

Of these products 33% were first in class, 39% had an orphan designation, 85% were approved on the first review, and 78% were approved first in the United States.

2018 looks to be just as busy for the FDA with many drugs slated for review or to be assigned for review.  Keeping track of all this movement can be challenging and let’s face it, very time-consuming.

In our maiden edition of the RJ Health FDA Actions Newsletter, our goal was to provide a summary of current month actions taken by the FDA and to provide a view into potential approvals in the coming month that are associated with specialty drugs.  We take pride in our monitoring process and wanted to share our expert insight with our colleagues in the industry.  We also hope that this information is helpful to you in tracking current and future drugs of relevance in the specialty market.

In January and February, there were a total of nine drug approvals by the FDA we deemed specific to the specialty market.  Two of these approvals were for novel therapeutic products, with the remaining being supplemental indications for products that are already marketed.  In addition to these approvals, the FDA had assigned seven new PDUFA dates and accepted filing for one biosimilar for approval review. Finally, there are four potential specialty products with PDUFA dates in March.

Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated administration by a professional, distribution by a specialty pharmacy or submission and reimbursement under the medical claim or Medicare Part B.

New Specialty Drug Approvals – New FDA drug approvals in the previous month

New Specialty Supplemental Indication Updates – Approved updated supplemental indications on currently marketed drugs in the previous month

Specialty Drug FDA Actions – New and supplemental FDA filings in the previous month

Looking Ahead – Anticipated FDA actions for specialty drugs in the next month

Below are links to more detailed publications regarding drugs included in the review above:

LUTATHERA ® (lutetium Lu 177 dotatate): Drug Alert – FDA Approval – lutetium Lu 177 dotatate injection, for intravenous use ( LUTATHERA ®)

Rituxan ® (Rituximab) Biosimilars: Rituxan (Rituximab) Biosimilars – 2018 Drug Pipeline Review

Terms & Abbreviations:

aNDA: Abbreviated New Drug Application
BLA: Biologics License Application
FDA: Food and Drug Administration
NDA: New Drug Application
sBLA: supplemental Biologics License Application
sNDA: supplemental New Drug Application
PDUFA: Prescription Drug User Fee Act: a law passed in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. By collecting the fee, the FDA is required to meet benchmarks related to the speed of the NDA/BLA review process
PDUFA Date: deadlines for the FDA to approve new drugs, typically 10 months from NDA/BLA completions, drugs selected for priority review may be allotted 6 months
sBLA: supplemental Biologics License Application
sNDA: supplemental New Drug Application

References:

U.S. Food and Drug Administration. Center for Drug Evaluation and Research Advancing Health Through Innovation 2017 New Drug Therapy Approvals. Downloaded February 16,2018. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf?utm_campaign=Advancing%20Health%20through%20Innovation%3A%20New%20Drug%20Approvals%20and%20Other%20Drug%20Therapy%20Advances%20of%202017&utm_medium=email&utm_source=Eloqua

Pharma Intelligence Center Web Site. Accessed February 28, 2018. https://pharma.globaldata.com

U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Accessed February 28, 2018.  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

U.S. Food and Drug Administration. Novel Drug Approvals for 2017. Accessed February 28, 2018.  https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm