5 New FDA Approvals to Know from October 2017

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

1. Bydureon BCise

The FDA approved AstraZeneca’s exenatide extended-release injectable suspension (Bydureon BCise) on October 23, 2017.¹

Bydureon BCise is indicated for the improvement of glycemic control in adults with type 2 diabetes whose blood sugar remains uncontrolled on 1 or more oral medications.

The drug is to be used once-weekly with a single-dose autoinjector device designed to provide consistent therapeutic levels of exenatide via a continuous-release microsphere delivery system.

The most common adverse events reported by trial patients treated with Bydureon BCise were nausea and reactions associated with injection-site nodules.

2. Ingrezza

The FDA approved an 80-mg capsule strength of Neurocrine Biosciences’ valbenazine (Ingrezza) on October 5, 2017.²

Ingrezza initially received the agency’s nod for the treatment of adults with tardive dyskinesia (TD) on April 11, 2017, making it the first product approved for this purpose.

The drug, a selective VMAT2 inhibitor taken once per day, works by reducing the amount of dopamine released in the part of the brain that controls movement and motor function, which helps to regulate nerve signaling in adults with TD.

Neurocrine Biosciences plans to make the 80 mg Ingrezza tablet available through a select pharmacy network.

3. Lyrica CR

The FDA approved pregabalin extended-release tablets CV (Lyrica CR) on October 12, 2017.³

Lyrica CR is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). The drug, however, did not receive approval for the management of fibromyalgia.

The most common adverse events associated with the use of Lyrica CR include dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

4. Simponi Aria

The FDA expanded the label of Janssen’s golimumab (Simponi Aria) on October 20, 2017.⁴

Simponi Aria, initially approved in 2013 for the treatment of moderately to severely active rheumatoid arthritis, is now also indicated for the treatment of adults with psoriatic arthritis and the treatment of adults with active ankylosing spondylitis.

The drug is currently the only fully-human anti-tumor necrosis factor alpha therapy that is administered with a 30-minute infusion.

5. Zilretta

The FDA approved Flexion Therapeutics’ triamcinolone acetonide extended-release injectable suspension (Zilretta) on October 6, 2017.⁵

Zilretta is indicated for the treatment of osteoarthritis knee pain. The drug, which utilizes Flexion’s microsphere technology, is the first and only extended-release, intra-articular injection to receive the FDA’s nod for this purpose.

Flexion plans to launch the drug in the United States during the fourth quarter of 2017.

References

• US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes [news release]. AstraZeneca’s website. https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-approves-new-easy-to-use-once-weekly-bydureon-bcise-injectable-medicine-for-patients-with-type-2-diabetes-231017.html. Accessed October 23, 2017.
• Neurocrine announces FDA approval of 80 mg Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD) [news release]. Neurocrine’s website. http://phoenix.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=2304824. Accessed October 6, 2017.
• US FDA approves Lyrica CR (pregabalin) extended-release tablets CV [news release]. Pfizer’s website. http://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lyrica_cr_pregabalin_extended_release_tablets_cv. Accessed October 12, 2017.
• Janssen receives two US FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis [news release]. Janssen’s website. https://www.jnj.com/media-center/press-releases/janssen-receives-two-us-fda-approvals-for-simponi-aria-golimumab-for-the-treatment-of-adults-with-active-psoriatic-arthritis-or-active-ankylosing-spondylitis. Accessed October 20, 2017.
• Flexion Therapeutics announces FDA approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis (OA) knee pain [news release]. Flexion’s website. https://globenewswire.com/news-release/2017/10/06/1142458/0/en/Flexion-Therapeutics-Announces-FDA-Approval-of-Zilretta-triamcinolone-acetonide-extended-release-injectable-suspension-for-Osteoarthritis-OA-Knee-Pain.html