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Second Cycle Re-Evaluation Memo- Berinert, August 20, 2009
|Date:||August 20, 2009|
|From:||Jean Makie, M.S., R.D., Regulatory Review Officer|
Advertising and Promotional Labeling Branch (APLB) (HFM-602)
Division of Case Management (DCM)
|Through:||Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, (HFM-602)|
|To:||Nannette Cagungun, RPM, OBRR, DBA, RPMB (HFM-380)|
Felice D’Agnillo, Committee Chair, OBRR, DH, LBVB (HFM-343)
Ross Pierce, Medical Officer, OBBR, DH, CRB (HFM-392)
|Subject:||Re-evaluation of proposed proprietary name Berinert|
(C1 esterase inhibitor) BLA STN: 125287/0
|Recommendation:||Berinert proprietary name be found Acceptable|
CSL Behring (CSL) submitted a Complete Response (CR) for Berinert on April 10, 2009. CSL contracted with the Drug Safety Institute (DSI) to conduct a second Risk and Gap Analysis to reevaluate Berinert for this CR submission. The DSI report, submitted July 1, 2009, concluded that Berinert remains an acceptable name for a C1 inhibitor (human). CSL Behring has manufactured and sold C1-INH concentrate as “Berinert® P” for over 20 years in Germany, Austria, Switzerland, and several other countries.
Berinert [C1 inhibitor (Human)] is a sterile, stable, lyophilized preparation of highly purified C1 inhibitor derived from human plasma. Berinert will be indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients. Berinert will be available in single-use vials that nominally contain 500 Units (U) human C1 inhibitor and will be reconstituted with 10 mL of Sterile Water for Intravenous Injection (supplied). The recommended dose of Berinert is 20 units per kilogram body weight, at a rate of approximately 4 mL per minute. Berinert will be administered both in a hospital setting and by the patient after self-administration instructions are provided by the healthcare practitioner.
APLB has performed a re-evaluation of the proposed proprietary name Berinert, to determine if any new products have been approved since our previous review on September 30, 2008 (first cycle; please see EDR for complete review memo). APLB found that no new products have been approved that would change our previous recommendation. APLB recommends that the proposed proprietary name Berinert be found Acceptable.
Proposed Proprietary Name Evaluation:
APLB re-reviewed the proprietary name to ensure that our review is within 90 days of approval. The PDUFA goal date is October 10, 2009. There were no newly marketed products whose names resembled Berinert from a potential look-alike or sound-alike perspective.
Of interest, OBBR approved Cinryze, another C1 esterase inhibitor (human), on October 10, 2008. Cinryze is indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. Cinryze is also a lyophilized preparation available in a single-use vial that contains 500 Units (U) human C1 inhibitor. Each vial must be reconstituted with 5 mL Sterile Water for Injection, USP (not supplied). Two reconstituted vials must be used to make a single, 1,000 Units, dose. According to its PI, a dose of 1,000 Units CINRYZE can be administered at a rate of 1 mL/minute, every 3 or 4 days, for routine prophylaxis against angioedema attacks in HAE patients.
Despite the commonalities of similar proper name, indicated patient population, dosage form and route of administration (intravenous), from a potential look-alike or sound-alike perspective, the proposed trade name, Berinert, does not resemble the approved trade name, Cinryze.
APLB recommends that the proposed proprietary name Berinert be found acceptable at this time. No recently approved products whose names resemble Berinert were found.
- http://www.fda.gov/cder/ob (Electronic Orange Book), Current through June, 2009; searched 8/17/09
- http://www.rxlist.com.(RxList); searched 8/17/09
- http://www.accessdata.fda.gov/scripts/cder/drugsatfda (CDER New and Generic Drug Approvals); searched 8/17/09
- CBER New BLA, NDA and ANDA approvals lists (updated 8/18/09); searched 8/18/09
- http://www.accessdata.fda.gov/scripys/cder/ndc/gettradename.cfm; (Current through June 29, 2009); searched 8/17/09
- http://cdspoca.cder.fda.gov/POCA/search.aspx, searched 8/18/09.