What You Missed From The FDA Last Week—August 11-15, 2014

FDA Approves Millennium’s Velcade

Takeda’s Millennium announced that Velcade was approved for the retreatment of adults with multiple myeloma (MM) who had previously seen positive results from treatment with Velcade and that had relapsed within 6 months following that prior treatment. The labeling update covers dosing guidelines and includes the safety and efficacy findings for Velcade as both a single agent and in combination with dexamethasone in patients previously treated with Velcade.  The sNDA was supported by results from the international phase 2 RETRIEVE study that demonstrated the drug achieved a 38.5 percent overall response rate in MM patients previously treated by Velcade.

Diabetes Drug Invokamet Gets FDA Nod of Approval

Janssen’s Invokamet was approved by the FDA last week for the treatment of adults with type 2 diabetes. The drug is a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet. However, the drug is also to be taken in addition to proper diet and exercise to improve glycemic control. Invokamet is not to be used to treat type 1 diabetes or for the treatment of diabetic ketoacidosis. The pill is to be taken twice a day and is available in tablets containing 50mg or 150 mg of canagliflozin, or 50mg and 1000mg of metformin.

Mirati Therapeutics DLBCL Drug Receives Orphan Designation

Spectrum selective HDAC inhibitor mocetinostat was granted orphan drug designation by the FDA last week for the treatment of diffuse large B-cell lymphoma (DLBCL). The drug has also been given orphan designation in myelodysplastic syndrome (MDS). Mirati is also attempting to gain orphan designation for the drug in the treatment of bladder cancer with specific genetic alterations in Histone Acetyl Transferases (HATs). The company is currently enrolling participants for a phase 2 dose finding study of mocetinostat in combination with Vidaza for intermediate and high-risk MDS. Phase 2 trials in DLBCL and bladder cancer with mutations in HATs are upcoming. Data from ongoing trials is expected by the end of the year. 

OncoSynergy OS2966 For Glioblastoma Named Orphan Drug

The FDA granted orphan drug designation to OncoSynergy’s glioblastoma candidate OS2966. The candidate is a neutralizing anti-CD29 monoclonal antibody that aims to halt the growth and progression of tumors by selectively modulating CD29 (integrin b1 subunit).

Merck’s Belsomra Given Green Light By FDA

Merck announced that its Belsomra (suvorexant) received approval from the FDA for patients encountering difficulties falling asleep and staying asleep. An orexin receptor agonist, Belsomra is the first approved drug of its type. Orexin is responsible for regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling action of orexin in the brain and is available in four different doses: 5, 10, 15, and 20 mg. However, the drug has been shown to impair next-day driving performance in patients following treatment.

Genentech’s Avastin Granted FDA Approval

Genentech’s cervical cancer drug Avastin received approval from the FDA for the treatment of persistent, recurrent, or late-stage cervical cancer. Avastin interferes with blood vessels that encourage cancer cells to develop. The new indication will enable the drug to be taken in combination with paclitaxel and cisplatin, or in combination with paclitaxel and topotecan. This is the first drug approved for cervical cancer since 2006 when topotecan in combination with cisplatin was approved, the FDA said. Avastin was granted approval under the priority review program. In clinical trials that involved 452 patients with cervical cancer, the drug in combination with chemo improved overall survival, bringing survival up to 16.8 months compared to 12.9 months in those only receiving chemotherapy.

FDA Advisory Committee Recommends COPD Treatment

Boehringer Ingelheim’s investigational tiotropium bromide inhalation spray for the treatment of bronchospasm in chronic obstructive pulmonary disease (COPD) was recommended for approval by the FDA’s Pulmonary-Allergy Advisory Committee (PADAC). The drug is administered via the Respimat multi-dose, propellant-free inhaler. Should the FDA approve the treatment, the proposed proprietary name will be Spiriva Respimat. The committee based their vote following review of data from eight efficacy trials enrolling 8,700 patients. The TIOSPIR trial in particular gathered data from more than 17,000 COPD patients in 50 countries across the globe, making it the largest clinical trial conducted to date in COPD.

FDA Accepts Pfizer Vaccine For BLA Priority Review

Pfizer announced that the FDA accepted its Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086)—a vaccine for the treatment of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. This BLA was also granted priority review, with an estimated Prescription Drug User Fee Act (PDUFA) action date of February 14, 2015. rLP2086 contains two antigens, or factor H binding proteins (fHBP) from both subfamily A and subfamily B. The company is currently completing a clinical development program, which includes phase 2 and 3 trials evaluating the treatment in approximately 14,000 patients out of an overall pool of 20,000. The phase 3 program began in November of 2012; immunogenicity and safety studies are currently ongoing.