FDA Approves Inrebic Capsules for Myelofibrosis

FRIDAY, Aug. 16, 2019 -- Inrebic (fedratinib) capsules have been approved to treat adults with intermediate-2 or high-risk primary or secondary myelofibrosis, making it the second drug approved to treat patients with this disease, the U.S. Food and Drug Administration announced today.

Approval of Inrebic for patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis was based on clinical trial data from 289 patients randomly assigned to 400 or 500 mg of oral Inrebic daily or placebo. Thirty-six percent of patients (35 of 96) treated with the label-recommended dose of 400 mg of Inrebic had experienced at least a 35 percent reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging or computed tomography scan. Thirty-six patients treated with Inrebic had at least a 50 percent reduction in myelofibrosis-related symptoms, including night sweats, itching, abdominal discomfort, feeling full sooner than normal, rib pain on the left side, and bone or muscle pain.

Pretomanid Approved for Treatment of Drug-Resistant TB

WEDNESDAY, Aug. 14, 2019 -- Pretomanid tablets in combination with bedaquiline and linezolid have been approved for the treatment of a highly treatment-resistant type of pulmonary tuberculosis (TB), the U.S. Food and Drug Administration announced today.

The treatment combination was approved to treat adult patients with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary TB. Dosing involves 200 mg of Pretomanid tablets orally once daily for 26 weeks, 400 mg of bedaquiline orally once daily for two weeks followed by 200 mg three times per week for 24 weeks, and 1,200 mg of oral linezolid daily for up to 26 weeks.

Drug Approved to Treat Tenosynovial Giant Cell Tumor

MONDAY, Aug. 5, 2019 -- Turalio (pexidartinib) capsules have been approved to treat adults with symptomatic tenosynovial giant cell tumor (TGCT), the U.S. Food and Drug Administration announced.

The drug was approved for patients with TGCT with severe morbidity or functional limitations that has not improved with surgery. Turalio is only available through the Risk Evaluation and Mitigation Strategy Program.

FDA Grants First Approvals for Generic Versions of Lyrica

TUESDAY, July 23, 2019 -- Nine drug companies have received approval for the first generic versions of Lyrica (pregabalin), the U.S. Food and Drug Administration announced.

The generic versions of Lyrica have been approved to manage neuropathic pain from diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia. The agency also approved the generic versions as adjunctive therapy for partial onset seizures in patients aged 17 years and older.

Recarbrio OK'd for Complicated Urinary Tract, Intra-Abdominal Infections

THURSDAY, July 18, 2019 -- The antibacterial drug product Recarbrio (imipenem, cilastatin, and relebactam) has been approved to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in adults, the U.S. Food and Drug Administration announced.

Recarbrio, a three-drug combination injection, is intended to be used for patients who have limited or no alternative antibacterial drugs to treat their infection, Ed Cox, M.D., M.P.H., director for the Office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research, noted in an FDA release. The recommended dose is 1.25 g administered by intravenous infusion for 30 minutes every six hours in patients aged 18 years or older with creatinine clearance of at least 90 mL/minute.

Xpovio With Dexamethasone Approved for Refractory Multiple Myeloma

TUESDAY, July 9, 2019 -- Xpovio (selinexor) tablets have been approved for use in combination with dexamethasone to treat adults with relapsed refractory multiple myeloma, the U.S. Food and Drug Administration announced last week.

The drug combination was granted accelerated approval for patients whose disease remains resistant to other treatments, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Soliris Approved to Treat Neuromyelitis Optica Spectrum Disorder

FRIDAY, June 28, 2019 -- The U.S. Food and Drug Administration has approved Soliris (eculizumab) injection as the first treatment for neuromyelitis optica spectrum disorder (NMOSD), the agency announced Thursday.

Soliris is indicated for intravenous use (300 mg/30 mL injection) in patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive.

FDA Expands Cystic Fibrosis Treatment Approval to Children Ages 6 to 12

MONDAY, June 24, 2019 -- The indication for a cystic fibrosis treatment, Symdeko (tezacaftor/ivacaftor) tablets, has been expanded to treat children ages 6 years and older with cystic fibrosis and certain genetic mutations, the U.S. Food and Drug Administration announced today.

Symdeko is approved to treat patients with two copies of the F508del mutation, the most common type of mutation, and patients who have at least one of the mutations in the CFTR gene that is responsive to the active ingredients in Symdeko. The FDA approved Symdeko last year for treatment in children ages 12 years and older with the same genetic mutations. Dosage in children ages 6 to 12 years weighing less than 30 kg is one tablet of 50 mg tezacaftor and 75 mg ivacaftor in the morning and one tablet of 75 mg ivacaftor approximately 12 hours later. In patients aged 12 years and older or who weigh 30 kg or more, dosage is one tablet containing 100 mg tezacaftor and 150 mg ivacaftor and a tablet containing 150 mg ivacaftor 12 hours later.

FDA Approves Victoza Injection for Children 10 Years and Older

TUESDAY, June 18, 2019 -- Victoza (liraglutide) injection is now approved to treat type 2 diabetes in children 10 years and older, the U.S. Food and Drug Administration announced.

Approved to treat type 2 diabetes in adults in 2010, Victoza is the first noninsulin drug to be approved to treat type 2 diabetes in children since metformin in 2000. Victoza's labeling states that the injection is not a substitute for insulin and is not indicated for patients with type 1 diabetes or those with diabetic ketoacidosis. Dosage of Victoza in children should start at 0.6 mg daily for at least one week. The manufacturer's prescribing information indicates that if additional glycemic control is required, the dose should be increased to 1.2 mg daily, and then to 1.8 mg daily after at least one week of treatment with the 1.2-mg daily dose if additional control is still required.

Zerbaxa Approved for Hospital-Acquired Bacterial Pneumonia

TUESDAY, June 11, 2019 -- Zerbaxa (ceftolozane and tazobactam) has been approved for a new indication to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older, the U.S. Food and Drug Administration announced yesterday.

In 2014, the FDA first approved Zerbaxa for treating complicated intra-abdominal infections and urinary tract infections. According to the manufacturer's prescribing information, Zerbaxa is administered in a recommended dosage regimen of a 1.5-g injection every eight hours by intravenous infusion for one hour. Treatment duration should be based on the infection site and severity and the patient's progress.