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Weekly Drug News Round-Up: December 23, 2015

AstraZeneca’s Zurampic Cleared for Hyperuricemia Associated with Gout

Zurampic has a boxed warning detailing the risk for acute kidney (renal) failure Read More...

Gout is a painful form of arthritis caused by the buildup of uric acid in the body, often first noticed as a red, swollen, throbbing toe. Zurampic (lesinurad) is an oral selective uric acid reabsorption inhibitor (SURI) indicated for the combination treatment of hyperuricemia associated with gout. Zurampic works by helping the kidney excrete uric acid. The FDA has approved Zurampic to be used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Commons side effects in clinical trials included headache, influenza, increased blood creatinine, and gastroesophageal reflux disease. 

Actelion’s Uptravi Approved for Pulmonary Arterial Hypertension

Uptravi was granted orphan drug designation Read More...

The FDA has approved Actelion’s Uptravi (selexipag), a potent, orally available, selective IP prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension in adults. Pulmonary arterial hypertension (PAH) is a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. In clinical trials, Uptravi was shown to be effective in reducing hospitalization for PAH and reducing the risks of disease progression compared to placebo. Common side effects included headache, diarrhea, jaw pain, nausea, muscle pain (myalgia), vomiting, pain in an extremity, and flushing.

Basaglar Wins Approval for Type 1 and Type 2 Diabetes

Basaglar is administered subcutaneously once daily at the same time Read More...

The FDA has approved Eli Lilly’s and Boehringer Ingelheim’s Basaglar (insulin glargine), a long-acting human insulin analog indicated to improve glycemic control in patients with type 1 and type 2 diabetes mellitus. Although Basaglar is not approved as a biosimilar product, the sponsors submitted data through an abbreviated approval pathway that relied, in part, on the FDA’s finding of safety and effectiveness for Lantus (insulin glargine injection). The most common side effects with Basaglar include hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema (fluid retention) and weight gain.

Keytruda Gains New Indication for Advanced Melanoma

Keytruda is the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status Read More...

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody used for the treatment of metastatic non-small cell lung cancer and metastatic melanoma. This past week, FDA expanded the use of Keytruda to include the first-line treatment of patients with unresectable or metastatic melanoma. In trials, patients given Keytruda 10 mg/kg every two weeks demonstrated a 37 percent reduction in the risk of death and those given Keytruda 10 mg/kg every three weeks demonstrated a 31 percent reduction in the risk of death, both compared to ipilimumab (Yervoy). Common side effects included fatigue, diarrhea, rash, and nausea.

FDA Eliminates REMS for Rosiglitazone Diabetes Drugs

FDA has determined the REMS is no longer needed to ensure benefits of rosiglitazone medicines outweigh their risks Read More...

In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that this drug did not increase risk of heart attack compared to the standard type 2 diabetes medicines metformin and the sulfonylurea class. Manufacturers have also fulfilled the required educational training for health care professionals about heart risks with rosiglitazone. Now, FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics.