FDA News Roundup: MedImmune, Celgene, Lundbeck, And More

MedImmune’s MEDI3902 Fast-Tracked

AstraZeneca’s R&D arm, MedImmune, received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 indicated to prevent Pseudomonas aeruginosa (P. aeruginosa)-caused pneumonia. The drug is entering Phase 1 clinical trials after several preclinical animal trials showed that MEDI3902 held its own in preventing and treating the bacterial infection in various animal models. MEDI3902 is part of MedImmune’s growing pipeline of candidates targeting other bacterial pathogens, such as MEDI4893, which is indicated to tackle the Staphylococcus aureus alpha toxin.

NOXXON’s Olaptesed Pegol Named Orphan Drug

NOX-A12, a Spiegelmer therapeutic from NOXXON Pharma, was awarded Orphan Drug Designation from the FDA for glioblastoma in conjunction with radiotherapy. The drug candidate, olaptesed pegol, is a PEGylated mirror-image (L-) oligonucleotide which controls tumor progression. Treatment with olaptesed pegol can help make tumors more vulnerable to chemotherapy and radiation, as well as halt tumor repair mechanisms. There are currently two ongoing Phase 2a studies investigating olaptesed pegol’s impact on multiple myeloma and chronic lymphocytic leukemia.  

Lundbeck, Otsuka Await FDA Decision On Psychotropic Compound NDA

The FDA has accepted for review Otsuka and Lundbeck’s New Drug Application (NDA) for schizophrenia and major depressive disorder (MDD) treatment, brexpiprazole. The company expects the agency’s answer by July 11, 2015. The drug, a serotonin-dopamine activity modulator (SDAM), was put through seven Phase 2 and 3 clinical trials (three in schizophrenia and 4 in MDD), which both showed the drug made meaningful improvements to disease symptoms. 

NASH Drug Granted Fast Track Designation

Galmed’s aramchol, a once-daily, oral therapy for liver disease and cholesterol gallstones, was put on the fast track by the FDA as a potential treatment for Non-Alcoholic Steato-Hepatitis (NASH). As obesity and diabetes continue to become more serious health issues, the percentage of the population suffering from NASH is expected to increase from its current standing of 12 percent. The company plans to launch a Phase 2b clinical trial investigating the drug’s effect on 240 NASH patients that also suffer from obesity and insulin resistance. The trial will begin in Israel, Europe, and in several Latin American countries. The FDA approved the Investigational New Drug (IND) application for aramchol in July 2014.

Celgene’s Otezla Gains New Indication Approval

Celgene’s Otezla, currently approved for psoriatic arthritis, has now been given a nod to treat severe plaque psoriasis. The drug, known as an apremilast, will now be another player up against several big players in the market for this condition, including AbbVie’s Humira and Amgen’s and Pfizer’s Enbrel. Analysts associated with Bloomberg have predicted that the drug will rake in roughly $1 billion in sales by 2017. This might not be the end of the drug’s potential, either. The company is currently looking into the drug as a potential treatment for rheumatoid arthritis, as well as the type of arthritis implicated in the spinal condition ankylosing spondylitis.

Noven’s Minivelle Gains Post-Menopausal Osteoporosis Indication

Noven Pharmaceutical’s Minivelle patch (estradiol transdermal system), currently used to treat moderate to severe vasomotor symptoms in menopausal women, has now been approved to prevent postmenopausal osteoporosis. The newly approved patch is available in a 0.025 mg/day dosage, and is also 33 percent smaller than the 0.0375 mg/day dosage patch. The treatment is also available in 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day, however only the 0.025 mg/day dosage is indicated for osteoporosis.

Rexahn Wins Pancreatic Cancer Orphan Drug Designation

RX-3117, a cancer-specific nucleoside analog, was given orphan drug designation for the pancreatic cancer indication. The drug will be examined in a Phase 1b clinical trial, which is currently enrolling patients. In preclinical studies, the drug demonstrated its efficacy at maintaining anti-tumor activity in human cancer cell lines that are currently resistant to chemo drug, gemcitabine. Treatment for pancreatic cancer is becoming more in demand, especially considering 40 percent of patients become resistant to gemcitabine after 30 days. The drug is used to inhibit DNA and RNA synthesis, in turn causing the death of tumor cells. In preclinical studies, RX-3117 was beneficial in halting tumor growth in human cancer xenograft models of colon, lung, renal, and pancreatic cancer.