June 2016: Top FDA Approvals

Jentadueto XR Approved for Type 2 Diabetes

The US Food and Drug Administration (FDA) approved Jentadueto XR (linagliptin and metformin hydrochloride) extended-release tablets for adults with type 2 diabetes, Eli Lilly and Company announced in a statement.

The medication is a combination of 1000 mg of metformin with either 2.5 mg or 5 mg of linagliptin, a dipeptidyl peptidase-4 inhibitor. It is indicated as an adjunct to diet and exercise for the improvement of glycemic control in patients for whom treatment with both metformin and linagliptin is appropriate, the company noted.

The safety and efficacy were established based on studies of patients coadministered both medications whose type 2 diabetes was not adequately controlled with diet and exercise, as well as those taking a sulfonylurea in combination with diet and exercise. 

The boxed warning for the medication indicates a risk of lactic acidosis. Pancreatitis leading to death can also occur. 

The medication is not approved for use in patients with type 1diabetes.

This is the seventh treatment from the alliance between Boehringer Ingelheim and Lilly Diabetes that has received FDA approval in the past 5 years, Eli Lilly and Company noted.

FDA Grants Accelerated Approval to Ocaliva to Treat Patients with PBC

Intercept Pharmaceuticals announced that it has received accelerated approval from the US Food and Drug Administration for its drug Ocaliva (obeticholic acid), a farnesoid X receptor agonist, for the treatment of primary biliary cholangitis . 

Ocaliva is approved for use in combination with ursodeoxycholic acid in patients with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.

Although improvements in survival and disease-related symptoms have not yet been established, the drug’s ability to reduce alkaline phosphatase levels was established in Intercepts’s phase 3 POISE trial.

The most common side effect of Ocaliva is pruritus. Rash, oropharyngeal pain, dizziness, constipation, arthralgia, fatigue, abdominal pain and discomfort, thyroid function abnormality, and eczema were also observed during the trial in patients taking Ocaliva.

Zinbryta Approved to Treat Relapsing Forms of MS

The US Food and Drug Administration approved Zinbryta (daclizumab; Biogen, Inc), a long-acting injection that is self-administered monthly, to treat adults with relapsing forms of multiple sclerosis, the agency announced. 

The efficacy of the drug was established in 2 clinical trials, one comparing it with Avonex (interferon beta-1a), and one comparing it with placebo. In both trials, patients taking Zinbryta experienced fewer relapses. 

Zinbryta has a boxed warning regarding the potential for severe liver injury, which includes life-threatening events. Other risks associated with use of the medication include noninfectious colitis, lymphadenopathy, and skin reactions.

The most common adverse reactions include influenza, nasopharyngitis, upper respiratory tract infection, oropharyngeal pain, rash, dermatitis, eczema, and enlargement of lymph nodes.

Flucelvax Quadrivalent Has Been Approved

The US Food and Drug Administration has approved Flucelvax Quadrivalent, a 4-strain influenza vaccine, for patients aged 4 years and older.

The vaccine was developed to protect against 2 influenza A and 2 influenza B viruses.

Seqirus noted that, because Flucelvax Quadrivalent utilizes the same full-scale cell culture manufacturing technology and has compositions that overlap with Flucelvax (a trivalent vaccine), its clinical efficacy and safety data are relevant. In patients aged 18 to 49 years, Flucelvax showed efficacy against influenza caused by all circulating influenza strains (69.5%) and influenza caused by vaccine-like strains (83.8%), according to a company statement.

The most common adverse reactions include headache, myalgia, induration, fatigue, and injection site pain or erythema.

Indication for Invokamet Has Been Expanded

Janssen Pharmaceuticals announced that it has received expanded approval from the US Food and Drug Administration (FDA) for Invokamet (canagliflozin and metformin hydrochloride) as a first-line treatment of adult patients with type 2 diabetes.

As an adjunct to diet and exercise, Invokamet was first approved in 2014 to improve blood glucose control in patients with type 2 diabetes for whom blood glucose was not controlled adequately by either metformin or canagliflozin, as well as for patients treated with both medications separately.

The expanded approval is based on the results of a 26-week, multicenter, phase 3 study with more than 1100 participants. Patients taking a combination of canagliflozin and metformin experienced larger decreases in hemoglobin A_1C compared with patients in groups taking only one of the medications.

 Last week, the FDA alerted the public regarding interim safety results that showed an increase in leg and foot amputations for patients taking Invokamet and Invokana.

Tecentriq Approved to Treat Bladder Cancer

The US Food and Drug Administration (FDA) granted approval for Tecentriq (atezolizumab; Genetech) to treat patients with urothelial carcinoma.

 This drug is the first PD-1/PD-L1 inhibitor to treat this type of cancer.

 “Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells.”

 The medication was approved based on the results of a single-arm trial with 310 patients who had either locally advanced or metastatic urothelial carcinoma. The study found that 14.8% of patients experienced at least partial shrinkage of their tumor, according to a statement. The effect lasted 2.1 months to 13.8 months, the latter of which was at the time of the response analysis.

 The most common side effects associated with use of this drug include nausea, urinary tract infection, fatigue, decreased appetite, pyrexia, and constipation. It is also associated with immune-mediated side effects that can impact healthy organs.

Opdivo Approved to Treat Classical Hodgkin Lymphoma 

The US Food and Drug Administration granted accelerated approval for Opdivo (nivolumab; Bristol-Myers Squibb) to treat patients with classical Hodgkin lymphoma (cHL).

 The approval is based on 2 trials of patients with refractory or relapsed cHL.

 To determine efficacy, a study enrolled 95 patients who had been treated with autologous hematopoietic stem cell transplant (HSCT) and posttransplantation brentuximab vedotin. There was an overall response rate of 65%, 58% of patients experienced partial remission, and 7% complete remission.

 To determine safety, 263 patients, most of whom had received autologous HSCT, were enrolled. The most common adverse reactions were cough, fatigue, upper respiratory tract infection, pyrexia, and diarrhea. They also observed immune-mediated adverse reactions, which occurred in 1% to 5% of patients, including rash, hepatitis, hyperthyroidism, colitis, and pneumonitis.

 Serious adverse events occurred in 21% of patients, the most common of which include pneumonia, pyrexia, infusion-related reaction, pleural effusion, and rash.