MONDAY, Sept. 9, 2019 -- The U.S. Food and Drug Administration granted the first approval for a drug to slow the decline of pulmonary function in interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD), the agency announced Friday.
Ofev (nintedanib) capsules were approved in 2014 to treat adults with idiopathic pulmonary fibrosis and are now approved for patients with SSc-ILD. The recommended dosage is 150 mg twice daily 12 hours apart.
WEDNESDAY, Aug. 28, 2019 -- Nourianz (istradefylline) tablets have been approved as an add-on treatment to levodopa/carbidopa for adults with Parkinson disease experiencing "off" episodes, the U.S. Food and Drug Administration announced yesterday.
The drug is available in 20-mg or 40-mg doses, but the maximum recommended dosage in patients taking CYP3A4 inhibitors and those with moderate hepatic impairment is 20 mg once daily. The safety information for Nourianz states that use of the drug should be avoided in these patient populations.
MONDAY, Aug. 19, 2019 -- Rozlytrek (entrectinib), a kinase inhibitor, has received approval to treat adults and adolescents with cancer that carries the genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and has progressed following other treatment, the U.S. Food and Drug Administration announced last week.
The drug was also approved to treat adults with metastatic non-small cell lung cancer and ROS1-positive tumors. The recommended dose for adults with either indication -- NTRK gene fusion-positive tumors or ROS1-positive non-small cell lung cancer -- is 600 mg orally once daily. Dosage in adolescent patients aged 12 years and older is based on body surface area.
MONDAY, Aug. 19, 2019 -- The Barostim Neo System was granted U.S. Food and Drug Administration approval to treat symptoms of patients with advanced heart failure who are not candidates for treatment with other devices such as cardiac resynchronization therapy, the agency announced on Friday.
The device includes a pulse generator implanted below a patient's clavicle and connected to a lead attached to the carotid artery. A physician tests and programs the device after implantation. The Barostim Neo System delivers electrical impulses to baroreceptors to ultimately inhibit production of stress-related hormones and reduce heart failure symptoms. Indications for treatment with the device include regular heart rhythm, not being a candidate for cardiac resynchronization therapy, and left ventricular ejection fraction of ≤35 percent. Contraindications include anatomy that could impair device implantation, certain nervous system disorders, uncontrolled and symptomatic slow heart rate, atherosclerosis, and a known allergy to silicone or titanium.
MONDAY, Aug. 19, 2019 -- Xenleta (lefamulin) has been approved to treat adults with community-acquired bacterial pneumonia, the U.S. Food and Drug Administration announced today.
Dosing of Xenleta is either an oral administration of 600 mg every 12 hours or an intravenous administration of 150 mg every 12 hours for five to seven days. Patients can be started on either intravenous or oral therapy or can transition from intravenous to oral therapy to accelerate hospital discharge.
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.
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.
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.
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.
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.