FDA drug approvals December 2014


FDA actions in brief

FDA has approved the new drug application (NDA) for liraglutide [rDNA origin] injection (Saxenda, Novo Nordisk) , the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.


Accelerated approval for nivolumab (Opdivo, Bristol-Myers Squibb) has been granted for the treatment of patients who have unresectable or metastatic melanoma not responding to treatment with other drugs.


Lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) was approved for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).


Finafloxacin otic suspension (Xtoro, Alcon) was approved to treat acute otitis externa, commonly known as swimmer’s ear.


A screening test (The PLAC Test for Lp-PLA2 ActivitydiaDexus, Inc) that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks was cleared for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women.  


The first screening test (The EnLite Neonatal TREC KitWallac Oy, a subsidiary of PerkinElmer) was permitted to be marketed by for Severe Combined Immunodeficiency (SCID) in newborns. Babies with SCID appear normal at birth, but typically develop life-threatening infections within a few months. Without early intervention and treatment, death can occur within the baby’s first year; early detection and treatment can markedly improve survival. 

The expanded use of aripiprazole (Abilify MaintenaOtsuka and Lundbeck for extended-release injectable suspension was approved for the treatment of acutely relapsed adults with schizophrenia.

The first FDA-licensed supplemental test (MP Diagnostics HTLV Blot 2.4MP Biomedicals LLC) for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II) was approved. This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II

A new use has been approved for ruxolitinib (Jakafi, Incyte) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by FDA for this condition.

Blinatumomab (Blincyto, Amgen) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.

Rifapentine (Priftin, Sanofi) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients aged 2 years and older at high risk of progression to tuberculosis (TB) disease.



Complete response

Aspirin / omeprazole delayed release tablets (Yosprala 81/40 and 325/40, Pozen) for patients who require aspirin (1) to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, (2) to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, (3) to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, (4) in patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers. In the complete response letter (CRL), FDA used identical wording to that of the first CRL, which was that during an inspection of the foreign manufacturing facility of an active ingredient supplier on April 25, 2014, a FDA field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved. There were no clinical or safety deficiencies noted with respect to either Yosprala 81/40 or Yosprala 325/40 and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending. The supplier responded to FDA’s deficiencies in May, 2014 with a complete plan of action to correct all of the deficiencies noted. Since that time, the supplier has provided updates to the FDA on their progress on the action plan. During interactions today with the supplier, Pozen confirmed that there has been no new inspection of the facility from the compliance division at FDA since last April, and that the facility has received no communication or comment from the compliance division at the FDA with respect to the supplier’s action plan and progress on the plan to address the deficiencies, other than informing the supplier that the matter is under review and that the division has many competing priorities.

 Fixed-dose combination of nebivolol and valsartan (Actavis) for the treatment of hypertension.

Latanoprost BAK-free eyedrops (Sun Pharma Advanced Research). While FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA. SPARC believes that this additional information request from the FDA can be addressed on priority. 



Breakthrough designation

Ranibizumab injection (Lucentis, Genentech) for the treatment of diabetic retinopathy.

Recommended for approval

Ceftazidime-avibactam (Actavis) antibiotic to treat 2 infections caused by drug-resistant bacteria: Intra-abdominal infections and urinary tract infections, when limited or no alternative treatments are available, 

Priority review

Aflibercept (Eylea, Regeneron) Injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). In September 2014, FDA granted the drug breakthrough therapy designation for the treatment of diabetic retinopathy in patients with DME.

Fast-track designation

Antifungal drug nikkomycin Z (NikZ, University of Arizona) for treatment of Valley fever (coccidioidomycosis).

Necuparanib (Momenta) for the first-line treatment of metastatic pancreatic cancer in combination with Abraxane and Gemzar.



Orphan drug designation

Actimab-A (Actinium Pharmaceuticals), an alpha radiolabeled antibody being developed for newly diagnosed acute myloid leukemia in patients over the age of 60.

LTI-01(Lung Therapeutics Inc) for treatment of empyema, typically a complication of pneumonia.

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