FDA News

Endocrinology drug approvals from 2016

In a review of the 2016 milestones, Endocrine Today compiled a list of drugs related to the field that were newly approved. We put our best effort into making a complete list and regret any omission.

Appearance of a drug does not constitute any endorsement by Endocrine Today, its editors, publishers or editorial board.

Adlyxin (lixisenatide) — July

The FDA has approved the once-daily glucagon-like peptide-1 receptor agonist Adlyxin, a once-daily injection to improve glycemic control along with diet and exercise in adults with type 2 diabetes, Sanofi announced in a press release.

"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," Peter Guenter, executive vice president and head of the global diabetes and cardiovascular business unit at Sanofi, said in the release. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled." Read more.

Invokament XR (canagliflozin /metformin) — September

The FDA has approved a once-daily, fixed-dose combination therapy of the SGLT2 inhibitor canagliflozin and extended-release metformin for first-line use to treat type 2 diabetes, Janssen announced in a press release.

The first fixed-dose combination of canagliflozin and metformin (Invokana, Janssen) was initially approved by FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes not adequately controlled with metformin or canagliflozin alone, or who are already being treated with both medications separately. In May 2016, the FDA expanded the drug’s indication to include adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy. Read more.

Intrarosa (prasterone) — November

The FDA has approved prasterone for treatment of moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy, in postmenopausal women, according to an FDA press release.

Efficacy of prasterone (Intrarosa, Endoceutics Inc.), also known as dehydroepiandrosterone or DHEA, in a once-daily vaginal insert, was demonstrated through two 12-week placebo-controlled clinical trials that included 406 healthy postmenopausal women randomly assigned to prasterone or placebo. Prasterone significantly reduced the severity of pain during sexual intercourse compared with placebo, according to the release. The most commonly reported adverse events included vaginal discharge and abnormal Pap smear. Read more.

Lomaira (phentermine hydrochloride USP 8 mg) — November

The FDA has approved phentermine hydrochloride USP 8 mg, a low-dose medication for adults with obesity that can be taken up to three times daily, KVK Tech, Inc. announced in a press release.

The new lower-dose phentermine (Lomaira) is intended to be used for weight reduction as an adjunct to diet and exercise in adults with an initial BMI of at least 30 kg/m² or at least 27 kg/m² with at least one weight-related comorbidity, such as controlled hypertension, diabetes or high cholesterol. Read more.

Soliqua 100/33 (insulin glargine [Lantus]/ lixisenatide [Adlyxin]) injection — November

The FDA has approved a fixed-ratio combination of insulin glargine and lixisenatide injection for the treatment of type 2 diabetes, Sanofi announced in a press release.

The once-daily injection, also known as Soliqua 100/33, is a combination of insulin glargine 100 units/mL (Lantus) and the GLP-1 receptor agonist lixisenatide, and is intended for adults with type 2 diabetes inadequately controlled with less than 60 units per day of basal insulin or lixisenatide. Read more.

Xultophy 100/3.6 (insulin degludec [Tresiba]/liraglutide [Victoza]) injection November

The FDA approved a New Drug Application for a fixed combination of insulin degludec and liraglutide for the treatment of type 2 diabetes, Novo Nordisk announced in a press release.

The once-daily drug, also known as Xultophy 100/3.6 is a combination of insulin degludec injection (Tresiba) and liraglutide (Victoza) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily. Read more.

Synjardy XR (empagliflozin/metformin) — December

The FDA has approved Synjardy XR to control blood glucose levels in adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly announced in a press release.

When used along with diet and exercise, Synjardy, a combination of the SGLT2 inhibitor empagliflozin and metformin extended-release tablet, is indicated to improve blood glucose levels in adults with type 2 diabetes when both empagliflozin and metformin can be taken. Read more.