FDA News Roundup: Novo Nordisk, AstraZeneca, Merck, And More
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
What FDA decisions did you miss this week?
Curis DLBCL Drug Named Orphan Drug
The FDA granted Curis’ drug for Diffuse Large B-Cell Lymphoma orphan drug designation. CUDC-907 is a dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K). The oral treatment is currently being studied in a Phase 1 clinical trial enrolling patients with refractory lymphomas or multiple myeloma, and patients with advanced or relapsed tumors. The company expects to push the drug into a Phase 2 trial in the second half of 2015.
Aurobindo Wins Approval For Sildenafil Injection
The Hyderabad-based company has been granted the right to manufacture and market Sildenafil injection 10mg/12.5mL, which is bioequivalent and therapeutically equivalent to Pfizer’s Revatio injection for adults with pulmonary arterial hypertension. The drug is indicated for those who cannot swallow oral treatments.
Repros NDA Accepted For Review
The company’s NDA is for its enclomiphene citrate product, formerly known as Androxal. The drug is indicated for those who are overweight and suffering from secondary hypogonadism. This is currently Repros lead candidate, and should it be approved, the candidate will be the company’s first approved product.
Clovis Ovarian Cancer Drug Named Breakthrough Therapy
Rucaparib is indicated for those with advanced ovarian cancer with BRCA-mutated tumors who have seen their cancer progress following two rounds of platinum-based chemotherapy. The PARP inhibitor is an oral monotherapy being investigated for its safety and efficacy in the ARIEL study comprising two Phase 2 ovarian cancer trials. The company also has hopes the drug will be capable of treating ovarian cancer patients whose tumors behave like BRCA mutations, but are not mutant BRCA. The drug has already demonstrated some activity in this patient pool. The company has its sights set on 2016 to submit an NDA for rucaparib.
Glenmark Generic Given FDA Approval
Glenmark was granted approval to produce and distribute norethindrone acetate and ethinyl estradiol tablets 0.5 mg and 1 mg, the generic of Warner Chilcott’s FemHRT. The drug is indicated for moderate to severe vasomotor symptoms in women with menopause, as well as to prevent postmenopausal osteoporosis. With its generic, Glenmark is tapping into the $38.6 million FemHRT earned in annual sales last year.
Novo Nordisk Resubmissions Accepted For Review
The company’s Class 2 resubmissions for Tresiba and Ryzodeg were accepted for review by the FDA. The marketing application for Tresiba (insulin degludec) was originally submitted in 2013 with the combination therapy, Ryzodeg (insulin degludec/insulin aspart). However, because of concerns the insulin might increase the risk of heart attack and stroke, the FDA requested the company conduct the DEVOTE trial. Novo Nordisk is presenting interim data from DEVOTE to the FDA in support of its Class 2 resubmissions, with expectations the trial will conclude in late 2016. Tresiba is currently available in Europe and in other markets.
Merck Wins Two Breakthrough Therapy Designations
Merck’s grazoprevir/elbasvir won two new breakthrough therapy designations this week, just a few months following the FDA’s January decision to eliminate the breakthrough therapy designation previously awarded in 2013. The newest designation is for the drug as a treatment for HCV genotype 1 (GT1) with end stage renal disease on hemodialysis, and those with GT4. The company hopes to submit an NDA to the FDA within the first half of 2015. The drug is currently undergoing investigation in the Phase 3 C-EDGE program and the Phase 2b/3 C-SURFER study.
Prolong SCD Drug Granted Orphan Designation
The FDA awarded orphan drug designation for its Sanguinate as a treatment for sickle cell disease (SCD). The drug has vaso-constrictive properties to ensure oxygen is transported to oxygen-deprived cells and tissues, which could help eliminate many of the debilitating comorbidities—including vaso-occlusive crisis, Acute Chest Syndrome, and leg ulcers—associated with SCD.
Perrigo ANDA Approved
Perrigo’s ANDA for hydromorphone HCI extended-release tablets 8 mg, 12 mg, and 16 mg for chronic pain were approved. The drug is a generic for Mallinkrodt’s Exalgo, indicated for chronic pain in opioid-tolerant patients.
MedImmune Wins Fast Track Designation
The FDA has given MEDI18897 fast track designation. The drug is currently in development to treat those with lower respiratory tract illness in infants and children with respiratory syncytial virus (RSV). In clinical trials, the extended half-life monoclonal antibody is currently being studied in a Phase 1 clinical trial. AstraZeneca aims to develop the treatment to increase the antibody’s half-life so patients only need to take one dose of the drug during the RSV season.
Santhera DMD Drug Put On Fast Track
Raxone/Cantena for Duchenne Muscular Dystrophy (DMD) was granted fast track designation, supported by recent Phase 3 results showing that the drug slowed the degradation of lung function. The company is planning to submit an NDA in the near future. The candidate was previously named an orphan drug in the EU and U.S.
Neurotrope Earns Orphan Status For Fragile X Syndrome
The FDA named bryostatin an orphan drug for Fragile X Syndrome. The drug, an activator of Protein Kinase C (PKC), was licensed from Blanchette Rockefeller Neuroscience Institute, and is also currently under investigation in pre-clinical trials for the pediatric genetic disease Niemann-Pick type C.