FDA approves first treatment for all genotypes of hepatitis C in pediatric patients
On April 30, 2019 the U.S. FDA approved Mavyret® (glecaprevir/pibrentasvir) as the first and only treatment for all six subtypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret® was first approved in 2017 to treat HCV in adults. HCV is a serious viral infection of the liver that causes inflammation and, in some cases, liver failure. Clinical trials demonstrated that 100 percent of children who received Mavyret® for 8 or 16 weeks were considered cured of infection, with no detectable virus in the blood 12 weeks after treatment. Treatment of pediatric HCV before this approval required using different medicines for different subtypes of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 23,000 to 46,000 children in the U.S. with HCV infection.
FDA requires stronger warning labels on certain prescription sleep medicines
The FDA has announced they are requiring a new boxed warning and contraindication warning on three popular prescription medicines used for insomnia: eszopiclone (Lunesta®), zaleplon (Sonata®) and zolpidem (Ambien®, Ambien CR®, Edluar®, Intermezzo®, and ZolpimistTM). The new requirement is the result of a safety review conducted by the FDA that identified 66 cases of serious injury and death precipitated by complex sleep behaviors after taking these medicines. Complex sleep behavior refers to engaging in activities while not fully awake, such as sleepwalking and sleep driving. The FDA also issued a Drug Safety Communication to health care professionals and patients that summarizes the data that led to these warnings.
From the Industry
Could a diabetes drug reverse heart failure?
Researchers at Mount Sinai have demonstrated that antidiabetic drug Jardiance® (empagliflozin), produced by pharmaceutical company Boehringer Ingelheim, can reverse the progression of heart failure in non-diabetic animals. Results of their study, published in the Journal of American College of Cardiology, showed that Jardiance® may be able to help the heart function more efficiently. Significant cardiac benefits first observed in the EMPA-REG OUTCOME trial, published in January 2019, led the team of researchers to question if the drug contains a mechanism that is linked to heart failure prevention. Investigators tested this hypothesis in 14 non-diabetic pigs and discovered that all animals treated with Jardiance® experienced improved heart function compared to placebo. Jardiance® is currently undergoing Phase 3 clinicals trials for the treatment of heart failure and type 1 diabetes.
Recent FDA Approvals
New Drug Approval: Corlanor® (ivabradine)
Oral solution for the treatment of stable symptomatic heart failure in pediatric patients ages 6 months and older and to reduce the risk of hospitalization for worsening heart failure in adult patients [4/22/19 – Priority Review; Orphan Drug– AMGEN INC]
New Drug Approval: SkyriziTM (risankizumab-rzaa)
Subcutaneous injection for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy [4/23/19 – ABBVIE INC]
New Drug Approval: DuobriiTM (halobetasol propionate/tazarotene)
Topical lotion for the treatment of plaque psoriasis in adults [4/25/19 – BAUSCH HEALTH AMERICAS INC ]
New Generics Entering the Marketplace
Indication: overactive bladder
Dosage Form/Strength: 5MG, 10MG Tablets
Average Wholesale Price (AWP): Generic = 5MG ($440)/10MG ($440) | Brand = 5MG ($463)/10MG ($463)
Indication: bladder cancer
Dosage Form/Strength: 40MG/ML Intravesical Solution
Average Wholesale Price (AWP): Generic = 40MG/ML ($5,400) | Brand = 40MG/ML ($5,566)