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FDA Approves New Indication for Chronic Disease Treatment
The chronic disease treatment, Xywav, is approved to treat cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.
FDA recently approved a new indication for chronic disease treatment, Xywav, intended for adults with idiopathic hypersomnia (IH).
The oral solution is already approved to treat cataplexy or excessive daytime sleepiness in patients seven years of age or older with narcolepsy.
“A novel indication for Xywav is significant as the FDA has never granted an approval for idiopathic hypersomnia,” Eric Bastings, MD, deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the announcement.
“Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” Bastings continued.
FDA based its approval on a double-blind placebo-controlled trial testing the safety and effectiveness of Xywav in 154 adult patients with IH.
In the trial, patients who were randomized to switch from Xywav to placebo experienced worsening on measures of sleepiness and symptoms of IH compared to patients randomized to continued treatment with Xywav.
The most common adverse events in the trial were nausea, headache, dizziness, anxiety, and vomiting. Xywav is subject to strict controls on prescribing and dispensing under a program called a Risk Evaluation and Mitigation Strategy (REMS) due to its potential risks.
For example, under the Xywav REMS, only a certified prescriber at a certified pharmacy can prescribe the drug to an enrolled patient. Notably, Xywav will not be available in retail pharmacies.
FDA Approves Pfizer’s Vaccine for Tick-Borne Illness
FDA recently approved Pfizer’s TICOVAC for active immunization to prevent tick-borne encephalitis (TBE) in individuals one and older.
TICOVAC is currently the only FDA-approved vaccine to protect both children and adults against the TBE virus.
“We are proud to deliver the first vaccine to help protect people in the US against TBE, if they are traveling to any risk areas,” Nanette Cocero, PhD, global president of vaccines at Pfizer, said in the announcement.
“This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the US 45 years ago. This authorization helps to ensure that people from the US are also able to receive this vaccination if needed, reflecting our commitment to provide health for all,” Cocero continued.
CDC’s Advisory Committee on Immunization Practices (ACIP) will discuss recommendations on the safe and appropriate use of TICOVAC.
TBE is a viral infection of the brain and spine transmitted to humans through an infected tick bite. Over 35 countries across Europe and Asia have identified the infection. So far, more than 170 million doses of the vaccine have been distributed since 1976.
FDA Expands Label for Eli Lilly’s Rapid-Acting Insulin
FDA recently approved an expanded label for Eli Lilly and Company’s rapid-acting insulin, Lyumjev.
The agency approved the expanded label for Lyumjev 100 units/ milliliters, used to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.
“Insulin pumps are an important delivery option for people with diabetes – many of whom struggle with high postmeal blood sugar levels,” Leonard Glass MD, FACE., vice president of Medical Affairs at Eli Lilly and Company, said in the announcement.
“The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes. It is an exciting development for pump users seeking to manage their blood sugar levels and reduce postmeal spikes,” Glass continued.
FDA based its approval on results from a Phase 3 study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes.
The study, PRONTO-PUMP-2, met the primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Humalog. Specifically, Lyumjev elicited a superior reduction in blood glucose spikes at both one and two hours after a test meal compared to Humalog.
Currently, Lyumjev is available in the US and various global markets, including Japan and the European Union.
