4 New FDA Approvals to Know from July 2017

Learn about the new products and expanded indications approved by the FDA in July 2017.

1. Benlysta

The FDA approved a subcutaneous formulation of GSK’s belimumab (Benlysta) on July 21, 2017.¹

Benlysta, initially approved as an intravenous formulation in 2011, is indicated for the treatment of adult patients with active, autoantibody‑positive systemic lupus erythematosus (SLE) who are receiving standard therapy. With this latest nod, the new formulation of the drug has become the first subcutaneous self-injection treatment option for patients with SLE.

Common adverse events associated with the use of Benlysta include nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, extremity pain, depression, migraine, pharyngitis, cystitis, leukopenia, and viral gastroenteritis. The drug is contraindicated in patients who have had anaphylaxis with belimumab

GSK plans to launch the subcutaneous formulation of Benlysta in late August 2017.

2. Lusduna Nexvue

On July 20, 2017, the FDA granted tentative approval to Merck's insulin glargine injection 100 units/mL (Lusduna Nexvue), a follow-on biologic basal insulin for patients with type 2 diabetes that is administered through a pre-filled dosing device.²

Although Lusduna Nexvue met all regulatory requirements for follow-on biologics related to safety, efficacy, and quality, it is subjected to an automatic stay as the result of a patent infringement lawsuit in which Sanofi alleges that the drug infringes upon 10 patents for their own insulin glargine injection (Lantus).

Under the Hatch-Waxman Act, the 2016 lawsuit invoked a stay on the final approval of the drug for up to 30 months or if the court rules in favor of Merck.

3. Orencia

The FDA expanded the indication of Bristol-Myers Squibb’s abatacept (Orencia) on July 6, 2017.³

With this nod, intravenous and subcutaneous forms of Orencia are permitted to be used for the treatment of active psoriatic arthritis in adults. The drug, which works by inhibiting T-cell activation, was previously approved for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis.

The most common adverse events reported by trial participants treated with Orencia include headache, upper respiratory tract infection, nasopharyngitis, and nausea. Additionally, concurrent therapy with a TNF antagonist is not recommended due to an increased risk of infection.

4. Vosevi

The FDA approved Gilead Sciences’ sofosbuvir, velpatasvir, and voxilaprevir tablets (Vosevi) on July 18, 2017.⁴

Vosevi, a fixed-dose combination of a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor (sofosbuvir), an HCV NS5A inhibitor (velpatasvir), and an HCV NS3/4A protease inhibitor (voxilaprevir), is indicated for the treatment of adults with HCV genotypes 1 to 6 without cirrhosis or with mild cirrhosis.

Treatment recommendations for Vosevi are dependent on a patient’s viral genotype and prior treatment history. However, all patients should be tested for hepatitis B virus (HBV) prior to the initiation of therapy, as the drug carries a risk of HBV reactivation.

Other adverse events associated with the use of Vosevi include headache, fatigue, diarrhea, and nausea. The drug is contraindicated in patients taking rifampin.

References

• GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus [news release]. GSK’s website. https://www.gsk.com/en-gb/media/press-releases/gsk-receives-fda-approval-for-a-new-self-injectable-formulation-of-benlysta-belimumab-for-systemic-lupus-erythematosus. Accessed July 21, 2017.
• Merck announces US FDA grants tentative approval for Lusdana Nexvue (insulin glargine injection), a follow-on biologic basal insulin [news release]. Merck's website. http://www.mrknewsroom.com/news-release/research-and-development-news/merck-announces-us-fda-grants-tentative-approval-lusduna-. Accessed July 24, 2017.
• Bristol-Myers Squibb’s Orencia (abatacept) receives FDA approvals for treatment of active Psoriatic Arthritis (PsA) in adults [news release]. Bristol-Myers Squibb’s website. https://news.bms.com/press-release/rd-news/bristol-myers-squibbs-orencia-abatacept-receives-fda-approval-treatment-active. Accessed July 6, 2017.
• FDA approves Vosevi for Hepatitis C [news release]. FDA’s website. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm567467.htm. Accessed July 18, 2017.