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FDA drug approvals-March 2015


FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations

FDA actions in brief

FDA has approved a new administration option for ticagrelor (BrilintaAstraZeneca) in acute coronary syndrome patients who are unable to swallow Brilinta 90-mg tablets whole. Unlike other P2Y12 inhibitors, Brilinta can be crushed and administered in water by swallowing or via nasogastric tube.  

A label update was approved for abiraterone acetate (ZytigaJanssen) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.

An expanded use for aflibercept (Eylea, Regeneron) injection was approved to treat diabetic retinopathy in patients with diabetic macular edema.

Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV (Quadracel, Sanofi-Pasteur) vaccine was approved for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4 through 6 years.

Anthrax Immune Globulin Intravenous (Human) (AnthrasilEmergent BioSolutions) also known as AIGIV, was approved for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

Cholic acid (Cholbam, Asklepion Pharmaceuticals LLC) capsules were approved, the first FDA-approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

A supplemental new drug application (sNDA) for asenapine (Saphris, Actavis) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients aged 10 to 17 years. Saphris is the only atypical antipsychotic treatment option with a sublingual formulation.

Dinutuximab (Unituxin, United Therapeutics) was approved as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.

Isavuconazonium sufate (Cresemba, Astellas) antifungal was approved to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.

FDA has expanded the approved use of nivolumab (OpdivoBristol-Myers Squibb) was approved to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

FDA has launched its first mobile application (app) designed to provide quick access to important information on medications that are in short supply. Current or resolved drug shortages, as well as product discontinuations, can be identified by using the new app.


Breakthrough designation

Keyhole Limpet Hemocyanin (KLH)-based immunotherapy compound (Stellar Biotechnologies) for the treatment of adult patients with EGFRvIII-positive glioblastoma being developed by Celldex Therapeutics.


Complete response

Epinephrine (Adamis Pharmaceuticals Corporation) Injection USP 1:1000 0.3-mg pre-filled single dose syringe (PFS) product, for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction. The questions raised by the complete response letter from FDA pertain to Chemistry, Manufacturing and Controls (CMC) relating to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by FDA. No other safety or efficacy issues were raised, and the New Drug Application will remain open until the CMC issues are resolved.


NEXT: Fast track designations



Recommended for approval

Deoxycholic acid (ATX-101, Kythera Biopharmaceuticals) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin. If approved, ATX-101 would be a first-in-class submental contouring injectable drug.


Priority review

Cobimetinib (Genentech) in combination with vemurafenib (Zelboraf) for the treatment of BRAF V600 mutation-positive advanced melanoma.

Carfilzomib (Kyprolis, Amgen) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least 1 prior therapy. 


Fast-track designations

HS-410 (vesigenurtacel-L) (Heat Biologics) for the treatment of non-muscle invasive bladder cancer.

AXS-02 (Axsome Therapeutics) for treatment of pain associated with complex regional pain sydrome.

Asfotase alfa (Alexion Pharmaceuticals) for treatment in patients with hypophosphatasia.


Orphan drug designations

Ganaxolone (Marinus Pharmaceuticals, Inc), a synthetic analog of the endogenous neurosteroid allopregnanolone, for the treatment of protocadherin 19 gene (PCDH19) female epilepsy.

MBX-8025 (Cymabay), a selective agonist for the peroxisome proliferator-activated receptor delta, for treatment of the 3 lipid disorders associated with mixed dyslipidemia (abnormal lipid levels in the blood) as well as a majority of the cardiovascular risk factors that define metabolic syndrome. 

AG-348 (Agios) for pyruvate kinase deficiency.


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