Rx Products (July 2019)

MANUFACTURED BY: Eli Lilly and Co

INDICATION: The FDA recently approved Emgality (galcanezumab-gnlm) solution to treat episodic cluster headaches in adults. Given by patient selfinjection, Emgality is the first FDA-approved drug to reduce the frequency of episodic cluster headaches, which often occur at the same time of day for weeks or months at a time. The clinical trial for Emgality compared the drug with a placebo in 106 patients and found that patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline compared with 5.2 fewer attacks for patients on the placebo.

DOSAGE FORM: Subcutaneous injection

FOR MORE INFORMATION: emgality.com

PIQRAY

MANUFACTURED BY: Novartis Pharmaceuticals

INDICATION: The FDA has approved Piqray (alpelisib) tablets to treat postmenopausal women and men with hormone receptive—positive, human epidermal growth factor receptor 2–negative, PIK3CA-mutated, advanced or metastatic breast cancer, in combination with the FDA-approved endocrine therapy fulvestrant. Piqray is the first PI3K inhibitor to show a clinically meaningful benefit in this type of cancer. It is also the first new drug application for a new molecular entity to be approved under the FDA’s RealTime Oncology Review pilot program.

DOSAGE FORM: 50-, 150-, and 200-mg tablets

FOR MORE INFORMATION: us.piqray.com/metastatic-breast-cancer

IB-STIMMANUFACTURED BY: Innovative Health Solutions

INDICATION: The FDA has approved marketing of the IB-Stim, the first medical device to reduce functional abdominal pain caused by irritable bowel syndrome in patients aged 11 to 18 years. It is a nonsurgical device placed behind the ear that sends electrical impulses into cranial nerve bundles involved in processing pain. Patients can use the device continuously for 5 days, after which it must be replaced, for up to 3 consecutive weeks. In a clinical study including 50 patients, 52% of treated patients saw at least a 30% decrease in usual pain after 3 weeks.

DOSAGE FORM: Nonsurgical device

FOR MORE INFORMATION: ibstim.com

VICTOZA

MANUFACTURED BY: Novo Nordisk INDICATION: The FDA recently approved Victoza (liraglutide) injection to treat pediatric patients 10 years or older with type 2 diabetes (T2D). Although Victoza has been approved to treat adult patients with T2D since 2010, it is the first noninsulin drug approved to treat pediatric patients with T2D since 2000. The drug creates the same effects in the body as the glucagon-like peptide receptor protein in the pancreas, slowing digestion, preventing the liver from overproducing glucose, and helping the pancreas produce more insulin when needed.

DOSAGE FORM: Subcutaneous injection

FOR MORE INFORMATION: victoza.com