FDA News Roundup: Teva, AstraZeneca, Amgen, Medicines Company, And More

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

What FDA decisions did you miss this week?

Exelixis Drug Put On Fast-Track For RCC

Cabozantinib received fast-track designation as a second-line treatment for advanced renal cell carcinoma. The candidate inhibits the MET, VEGFRs, and RET tyrosine kinases, and is currently being investigated in the Phase 3 METEOR trial for patients who have been treated previously with another VEGF tyrosine kinase inhibitor. Endpoints include the drug’s impact on progression-free survival, overall survival, and objective response rate.   

Takeda, AstraZeneca Diabetes Drugs Raise FDA Concerns

AstraZeneca’s Onglyza (saxagliptin) and Kombiglyze (saxagliptin plus metformin) has raised some concerns from an FDA advisory committee that saxagliptin might increase the risk of heart failure and death. In clinical trials, patients demonstrated a 27 percent higher rate of being hospitalized for heart failure after receiving treatment with saxagliptin. The FDA advisory committee has recommended that there be a label update for Onglyza so patients are warned of the increased risk of heart failure while taking the drug.

The panel also met to discuss the risks associated with Takeda’s diabetes drug, Nesina. In reviewing data, the advisory committee found a statistically insignificant increase in the risk of heart failure. The committee still recommends that the drug’s label be updated, as reviewers are concerned the increased risk might be characteristic of the DPP-4 class, in which both Onglyza and Nesina are included.

Brain Cancer Treatment Named Orphan Drug

Nascent Biotech won orphan drug designation for its brain cancer treatment Pritumumab. In early non-clinical studies, results were similar to that of several human Japanese trials. Researchers expect that modifying the dose slightly for a U.S. population could make the drug effective domestically.  

Adamas Candidate Wins Orphan Designation

Adamas candidate ADS-5102 was granted orphan drug designation for Parkinson’s disease-associated levodopa-induced dyskinesia. The drug is being tested in several Phase 3 trials for this indication, which currently has no FDA-approved options on the market.

Horizon Garners Fast-Track Designation For FA Drug

A new treatment for Friedreich’s ataxia (FA), Actimmune (interferon gamma-1b), earned fast-track designation. The company filed the IND in February and is set to launch a Phase 3 clinical trial for FA in collaboration with the Friedreich’s Ataxia Research Alliance (FARA). There are currently no treatment options for those suffering from the neuro-muscular disorder. Actimmune already has two FDA approvals under its belt to treat infections brought on by chronic granulomatous disease, as well as to severe, malignant osteoporosis.

Reata Candidate Designated Orphan Drug For PAH

Bardoxolone methyl was named an orphan drug for pulmonary arterial hypertension (PAH). The drug demonstrated efficacy as an antioxidant, anti-inflammatory drug with bioenergetics properties in preclinical studies. It is now currently in the LARIAT Phase 2 dose-ranging study in order to determine the drug’s safety, tolerability, and efficacy.

ARCA Biopharma Earns Fast-Track Designation

Gencaro is a beta-blocker and mild vasodilator, indicated for the prevention of atrial fibrillation/atrial flutter in genetically modified heart failure patients. The Phase 2b/3 clinical GENETIC-AF clinical trial is currently undergoing, enrolling 200 patients with atrial fibrillation. The trial is expected to conclude at the end of 2016.

FDA Staff Back Medicines Co Approval

Cangrelor, an intravenous blood clot preventer, is indicated for those who have undergone angioplasty to keep coronary arteries open.  Last April, the company’s approval request was denied because reviewers had some concerns about the way the drug’s trial (Champion-Phoenix) was conducted. Following resubmission of the data, the reviewers found the drug was effective in lowering the combined risk of death, heart attack, and the need for repeated angioplasty and stent thrombosis. The review panel has given the drug a positive recommendation for approval. 

Aurobindo Generic Receives Approval

Cefixime for oral suspension, the generic of Lupin’s Suprax Oral Suspension USP 100 mg/5mL, was approved for adults and pediatric patients (six months +) to treat infections caused by organisms associated with urinary tract infections, uncomplicated gonorrhea, tonsillitis, chronic bronchitis, and other infections.

AstraZeneca Mesothelioma Treatment Granted Orphan Status

The FDA awarded tremelimumab, an anti-CTLA-4 monoclonal antibody for malignant mesothelioma. The drug is being examined in trials as a monotherapy for mesothelioma and in three different combinations: one with the investigational immunotherapy MEDI4736 as a treatment for NSCLC, head, and neck cancer; another with Iressa (gefitinib) in EGFR-mutated NSCLC; and with MEDI6469 for solid tumors. 

Amgen Heart Failure Drug Earns Nod Of Approval

Corlanor (ivabradine) is an oral treatment indicated for patients with worsening heart failure who have reached the limit for or have not seen success with beta blocker treatments. Through its inhibition of the “funny” current/the hyperpolarization-activated cyclic nucleotide-gated channel, the drug slows the heart rate, in turn cutting down on the number of hospitalizations patients had to undergo in the Phase 3 SHIFT study.  Corlanor is the first new chronic heart failure drug to win approval in a decade and holds the record of being Amgen’s first cardiovascular disease treatment. 

FDA To Review Teva NDA

Teva and Eagle Pharmaceutical’s liquid bendamustine hydrochloride for infusion is set to be reviewed by the FDA, with a PDUFA goal date in December. The treatment is indicated for rapid infusion for patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed following prior treatment. In trials, the treatment was successfully administered in ten minutes in a low-volume, 50 mL admixture.

FDA Approval Ushers In Competition For Teva Copaxone

The FDA announced approval of Sandoz’s and Momenta Pharma’s Glatopa, the generic for Teva’s blockbuster Copaxone. The drug is indicated for those with relapsing forms of MS. The company could not say when the drug will hit the market because of ongoing patent litigation, however Momenta expects the 20 mg generic could boast “substitutable” on its label, giving patients the option of receiving the generic. Teva is currently trying to sell patients on a 40 mg version of the drug that is still under patent protection in an effort to protect its blockbuster, which brought in $3.1 billion in sales for 2014.