FDA News Roundup: Bristol-Myers Squibb, Pfizer, Ariad, Salix, And More

Bristol-Myers Squibb Opdivo BLA Granted Priority Review

Bristol-Myers Squibb’s Biologics License Application (BLA) for its melanoma drug, Opdivo, was accepted for priority review by the FDA. The drug, an investigational PD-1 immune checkpoint inhibitor, was also granted accelerated review by the EMA. The FDA decision is expected by the end of March, 2015. The company included in its BLA results from a Phase 3 trial that investigated Opdivo’s ability to treat patients with unresectable or metastatic melanoma who previously received treatment with Yervoy. The drug’s performance was pitted against that of the dacarbazine (DTIC) or carboplatin/paclitaxel. In the trial, the drug achieved a 32 percent objective response rate in patients compared to the 11 percent response rate in patients treated with chemo. The company reports that these results are consistent with the results from an early Phase 1 trial.  

Alzheimer’s Drug Cleared For Clinical Trials

NeuroGenetic Pharmaceutical’s Investigational New Drug application (IND) received a nod of approval from the FDA, enabling the company to enter its “first in class” NGP 555 compound for Alzheimer’s disease into clinical trials by the end of the year. The drug completed all preclinical phases with the help of a fast-track grant from the National Institute of Neurologic Disease and Stroke (NINDS). In these studies, the drug positively affected amyloid biomarkers, pathology, and cognition, and resulted in fewer side effects than other compounds for preventing Alzheimer’s. The drug, available in novel solid dosage form, is a gamma-secretase modulator that affects a key enzyme in the amyloid pathway.

FDA Approves Chantix Label Revision

The FDA approved a label change for Pfizer’s Chantix  removing the warning that the drug causes suicidal tendencies in some patients. Since 2009, the label has been strongly warning patients about the drugs ability to incite aggression, depression, and suicidal behavior in patients following numerous suicide reports amongst people taking the drug. Following this recent FDA decision, the label will now include data from recent studies that found that there was little to no evidence that the drug caused psychiatric problems or suicidal tendencies in patients. In light of these results, Pfizer has now asked the FDA to consider completely removing the “black box label,” and over the next month, the FDA will be reviewing recent safety data in order to make a final decision on the matter.

 Hikma’s Colchicine Capsules Granted FDA Approval

Hikma Pharmaceuticals received approval for its New Drug Application for gout medication, colchicine 0.6 mg capsules. The company will be launching its drug under the brand name Mitigare and stands to see a boost in sales from the drug’s entrance into the market. According to Hikma’s release, sales of colchicine reached approximately $690 million over the past year.

Salix Relistor Given Green Light For OIC Treatment

Salix Pharmaceuticals garnered FDA approval for Relistor, its subcutaneous injection for opioid-induced constipation in adults being treated for non-cancerous pain.  The peripherally acting mu opioid receptor antagonist (PAMORA) underwent investigation in a Phase 3 clinical trial enrolling 312 patients and proved its efficacy in stimulating three or more spontaneous bowel movements (SBM) per week. Relistor Subcutaneous Injection first received FDA approval in 2008 for patients being treated for advanced illnesses who did not respond to treatment with laxatives.

Ariad AP26113 Named Breakthrough Therapy For ALK+ NSCLC

Ariad’s treatment for anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) received breakthrough therapy designation last week. Indicated for patients who are resistant to crizotinib, AP26113 was evaluated in a phase 1/2 clinical trial that enrolled 137patients and measured objective response rates. Of those enrolled in the trial, 72 percent of patients treated with AP26113 demonstrated an objective response. 

Sickle Cell Disease Drug Earns Fast Track Designation

NKT Therapeutics’ drug for sickle cell disease, NKTT120, was granted fast track designation last week. A humanized monoclonal antibody, the drug is responsible for decreasing the number of iNKT cells, which are often responsible for inflammation and organ damage in sickle cell disease.  The company recently completed dosing sickle cell disease patients in a Phase 1b clinical trial in order to determine the safety, as well as the drug’s effect on inflammation, daily pain scores, and Quality of Life.  NKTT120 previously received orphan drug designation from the FDA.

Halozyme’s PEGPH20 Named Orphan Drug

PEGylated recombinant human hyaluronidase (PEGPH20) was awarded orphan drug designation for pancreatic cancer, Halozyme announced.  A Phase 2 study is currently ongoing in an effort to determine the drug’s effect on patients when given in combination with gemcitabine and nab-paclitaxel (Abraxane) in metastatic pancreatic cancer.