Rx Product News (January 2021)

Marketed by AstraZeneca

The FDA has approved a new indication for ticagrelor to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack. Strokes are a leading cause of death and disability worldwide, and 1 in 4 patients who have had a stroke will experience a second one, according to a company statement. Ticagrelor is a well-established treatment for patients with coronary artery disease (CAD) and was approved in May 2020 to reduce the risk of a first heart attack or stroke in high-risk patients with CAD. Adverse effects can include bleeding more easily, bruising, cough, dizziness, headache, and nausea.

FOR MORE INFORMATION: brilinta.com

Sodium sulfate, magnesium sulfate, potassium chloride tablets (Sutab)

Marketed by Sebela

Pharmaceuticals Indicated for cleansing of the colon in preparation for colonoscopy in adults, Sutab tablets offer a new alternative to liquid-based colonoscopy solutions, which can be difficult and unpleasant to take. In 2 pivotal trials, 92% of patients achieved bowel cleansing with Sutab, and 92% to 95% of patients achieved successful cleansing in all segments of the colon, including the proximal colon. Most participants also said that it is easy to tolerate, and 78% said they would request Sutab again for a future colonoscopy. Adverse effects can include gastrointestinal issues, including nausea and vomiting.

FOR MORE INFORMATION: sebelapharma.com

Levonorgestrel, ethinyl estradiol patch (Twirla)

Marketed by Agile Therapeutics

Agile is launching the Twirla transdermal system, a nondaily, noninvasive contraceptive patch indicated for women of reproductive age with a body mass index of less than 30 for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. The patch is worn weekly and delivers a 30-μg daily dose of ethinyl estradiol, the lowest exposure of estrogen in a transdermal contraceptive option, as well as a 120-μg daily dose of levonorgestrel. The patch uses Skinfusion technology and is made up of 5 layers for focused drug delivery and to help maintain adhesion, according to a company statement.

FOR MORE INFORMATION: agiletherapeutics.com

Marketed by Merck

The FDA has approved a new indication for Merck’s pembrolizumab, an anti—PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic

triple-negative breast cancer in patients whose tumors express PD-L1 as determined by an FDA approved test. The approval is based on results from the phase 3 KEYNOTE-355 trial (NCT02819518),

where the combination was shown to significantly reduce the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone. Fatal

adverse events occurred in 2.5% of patients, including cardiorespiratory arrest and septic shock. Serious adverse reactions occurred in 30% of patients receiving pembrolizumab.

FOR MORE INFORMATION: merck.com