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.
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.
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.
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.
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.
TUESDAY, June 4, 2019 -- The U.S. Food and Drug Administration granted Emgality (galcanezumab-gnlm) solution the first approval for treating episodic cluster headache, the agency announced yesterday.
Previously approved for preventive treatment of migraine in adults, Emgality is administered through patient self-injection. The recommended dosage of Emgality for treatment of episodic cluster headache is 300 mg administered as three 100-mg injections at the initial onset of cluster headaches and then monthly doses of 120 mg until the end of the cluster period.
TUESDAY, June 11, 2019 -- The IB-Stim has received marketing approval from the U.S. Food and Drug Administration as the first medical device used to help alleviate functional abdominal pain in 11- to 18-year-old patients with irritable bowel syndrome (IBS), the agency announced Friday.
The prescription-only device is composed of a small single-use electrical nerve stimulator placed behind the patient's ear. A battery-powered chip in the stimulator emits low-frequency electrical pulses to continuously stimulate certain cranial nerve branches. The stimulator is replaced after five days, and patients can use the device for up to three consecutive weeks in combination with other IBS therapies.
TUESDAY, June 11, 2019 -- Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, received approval to treat patients with diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab, the U.S. Food and Drug Administration announced today. The combination was approved for patients whose disease has progressed or returned after at least two previous therapies.
Approval was based on a study of 80 patients with relapsed or refractory DLBCL randomly assigned to receive either Polivy with bendamustine and rituximab or bendamustine and rituximab alone. Researchers found a complete response rate of 40 percent with Polivy plus bendamustine and rituximab compared with 18 percent with bendamustine and rituximab alone. Twenty-five patients achieved a partial or complete response with Polivy plus bendamustine and rituximab; 64 percent of these patients had a duration of response of six months or longer and 48 percent achieved a duration of response of at least one year.
THURSDAY, May 30, 2019 -- The first test to detect the Zika virus in human blood has been approved by the U.S. Food and Drug Administration.
The test is called the ZIKV Detect 2.0 IgM Capture ELISA and is made by Seattle-based InBios, which makes tests for other viruses such as West Nile and dengue, CBS News reported. Until now, the only FDA-approved tests for Zika were used to detect virus antibodies and were only for emergency use.
TUESDAY, May 28, 2019 -- Piqray (alpelisib) tablets were approved for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer in combination with fulvestrant, the U.S. Food and Drug Administration announced Friday.
The tablets were approved for use in men and postmenopausal women whose disease progressed after treatment with an endocrine-based regimen. The drug was also approved in combination with a companion diagnostic test, the therascreen PIK3CA RGQ PCR Kit, which detects the PIK3CA mutation in a tissue or liquid biopsy. The recommended dose of Piqray is 300 mg (two 150-mg tablets) once daily, according to the manufacturer's prescribing information.