FDA News Roundup: Vertex, Merck KGaA , Bayer, And More
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
What recent FDA decisions have you missed lately?
FDA Approves Antibiotic For Plague
Avelox, indicated for plague, was approved by the FDA. The drug, manufactured by Bayer, was approved to treat pneumonic plague and septicemic plague, as well as to be a preventive tactic for adult patients. Efficacy data shows that African green monkeys treated with Avelox for 10 days survived the plague compared to monkeys being treated with the placebo.
Sucampo Cobiprostone Wins Fast Track Designation
Sucampo’s Cobiprostone, a locally acting chloride channel activator for oral mucositis, was put on the fast track. In addition to the Fast Track designation, the company received clearance to push the treatment into a proof-of-concept Phase 2 clinical trial for oral mucositis in patients with head and neck cancer receiving radiation and chemotherapy. In addition to the development program for oral mucositis, the drug is also in development for non-erosive reflux disease (NERD), a subtype of gastroesophageal reflux disease.
Vertex Gets FDA Committee Nod For Cystic Fibrosis Drug
An FDA advisory committee has given the thumbs up to Vertex Pharma’s Orkambi, a twice-a-day drug for cystic fibrosis—specifically for patients with two copies of the Fdel508 genetic mutation. Orkambi is a combination treatment comprising Kalydeco (ivacaftor), the company’s first drug for cystic fibrosis, and lumacaftor. The committee’s nod for approval came after some speculation that the drug did not provide more clinical benefit to the lungs compared to treatment with Kalydeco alone. In trials, the drug encouraged “a small but significant effect” on lung function, but it did not demonstrate quality of life or body weight benefits (secondary endpoints).
Antifungal Granted QIDP, Fast Track Designations
Cidara Therapeutics’ antifungal CD101 IV was put on the Fast Track and garnered a Qualified Infectious Disease Product designation for candidemia and invasive candidiasis. The company is preparing to submit an Investigational New Drug application (IND) and launch a Phase 1 clinical trial in the upcoming months.
Merck KGaA Pancreatic Cancer Drug Granted Fast Track Designation
Evofosfamide, a hypoxia-activated prodrug indicated for metastatic or unresectable pancreatic cancer, was granted Fast Track designation. The drug is indicated to be taken in combination with gemcitabine. This is the second fast track designation for evofosfamide, the first being given for soft tissue sarcoma, for which the drug is being examined in combination with doxorubicin in a Phase 3 clinical trial. Merck expects the Phase 3 MAESTRO trial in pancreatic cancer to be completed by the end of 2015. Other potential indications for evofosfamide include non-squamous non-small cell lung cancer, solid tumors, and blood diseases.
FDA Accepts Aspyrian IND For Review
RM-1929 will now be evaluated for approval for patients with recurrent head and neck cancer. Once in the body, the treatment targets an antigen common to various carcinomas and remains activated at the site of the cancer without destroying healthy tissues. The company expects to explore the antibody candidate’s effect on various other cancers in 2016 clinical programs.
Strides Arcolab Generic HIV Drug Wins Approval
Lamivudine and zidovudine oral tablets for HIV, the generic version of Viiv’s Combivir, were approved and are set to be manufactured in Bengaluru. These tablets are an antiretroviral indicated to be taken with other antiretrovirals for children and adults with HIV.
Pernix Therapeutics’ Migraine Treatment Given Green Light
Treximet is a combination of sumatriptan and naproxen sodium, indicated to relieve migraine pain in patients 12 and up. In a Phase 3 trial, the drug, a single 10/60 mg tablet taken once per 24-hour period, was more effective at eliminating pain in pediatric patients than the placebo.