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.

Emgality Receives First FDA Approval for Treating Cluster Headache

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.

Marketing OK'd for Device to Help Reduce IBS Symptoms in Adolescents

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.

Chemoimmunotherapy Regimen Approved to Treat DLBCL

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.

FDA Approves First Test for Zika in Human Blood

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.

First PI3K Inhibitor Approved for Metastatic, Advanced Breast Cancer

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.

FDA Approves First Gene Therapy for Spinal Muscular Atrophy

TUESDAY, May 28, 2019 -- The first gene therapy has been approved to treat children younger than 2 years with spinal muscular atrophy (SMA), the U.S. Food and Drug Administration announced Friday.

Zolgensma (onasemnogene abeparvovec-xioi), an adeno-associated virus vector-based gene therapy, targets the cause of SMA by delivering a fully functional copy of the human SMN1 gene into the target motor neuron cells. According to the FDA, a one-time intravenous administration of the drug yields expression of the SMN protein in a child's motor neurons, which improves movement, function, and survival. Dosing is based on patient weight, with a recommended dosage of 1.1 × 1.014 vector genomes per kilogram of body weight. Zolgensma is administered as an intravenous infusion for 60 minutes.