Rx Product News (December 2020)

Teva Respiratory, LLC

In addition to the ArmonAir Digihaler, Teva Respiratory is releasing the AirDuo Digihaler, a digital maintenance inhaler with fluticasone propionate and salmeterol inhalation powder for patients with asthma. The inhaler is indicated to control symptoms of asthma and to prevent symptoms such as wheezing in patients 12 years and older. It features built-in Bluetooth technology that connects to a companion mobile application, which provides information on inhaler use that is recorded as an event when the cap is opened or a patient inhales. A company statement noted that the offering is well timed because “digital health tools are more important than ever.”

FOR MORE INFORMATION: digihaler.com

IVACAFTOR (KALYDECO)MANUFACTURED BY: Vertex Pharmaceuticals Incorporated

The FDA recently approved ivacaftor for use in children aged 4 months to younger than 6 months who have at least 1 mutation in their CFTR gene that is responsive to the drug based on clinical and/or in vitro assay data. A company press release noted that initiating treatment for cystic fibrosis as early as aged 4 months may offer the potential to modify the course of the disease. This indication for ivacaftor is in addition to its 2012 approval for the treatment of cystic fibrosis in patients 6 months and older.

FOR MORE INFORMATION: kalydecohcp.com

APOMORPHINE HYDROCHLORIDE SUBLINGUAL FILM (KYNMOBI)MANUFACTURED BY: Sunovion Pharmaceuticals Inc

This apomorphine hydrochloride sublingual film is now available for the acute, intermittent treatment of off episodes in patients with Parkinson disease (PD). It is the first and only sublingual option for the on-demand treatment of PD off episodes. Because off episodes in PD can reduce motor function and limit an individual’s ability to perform daily activities, controlling these symptoms is essential.

FOR MORE INFORMATION: sunovionprofile.com/kynmobi

MEPOLIZUMAB (NUCALA)MANUFACTURED BY: GlaxoSmithKline plc

The FDA recently approved mepolizumab to treat adults and children 12 years and older with hypereosinophilic syndrome (HES) for 6 months or longer without an identifiable non—blood-related secondary cause. This approval makes mepolizumab the first and only targeted biologic treatment for patients with eosinophil-driven disease. Patients with HES, a rare disorder, have overproduction of eosinophilia, a type of white blood cell, which can lead to inflammation and organ damage. Adverse effects include abdominal pain, asthma, difficulty breathing, itching, muscle inflammation, and skin rashes. This is the third US indication for mepolizumab.

FOR MORE INFORMATION: nucala.com