On May 3, 2019, the U.S. FDA approved Vyndaqel® (tafamidis meglumine) and Vyndamax™ (tafamidis) capsules for the treatment of heart disease caused by transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) in adults. ATTR- CM is a debilitating and often fatal disease caused by abnormal buildup of protein deposits – known as amyloid – in the body’s organs and tissues. During a clinical trial of the drugs, 441 patients were randomly selected to receive Vyndaqel® or a placebo. After an average of 30 months, patients in the active drug group showed a higher survival rate and a lower number of heart related hospitalizations compared to the placebo group. The FDA granted Vyndaqel® Breakthrough Therapy, Fast Track, and Priority Review designations and both drugs received Orphan Drug designation.
On April 21, 2019, Alvogen, Inc. issued a national recall on two lots of fentanyl 12 mcg/h transdermal patches after it was discovered that a small number of cartons containing 50 mcg/h patches were labeled as 12 mcg/h patches. Transdermal fentanyl is indicated for the management of pain in patients who have previously received opioids and are opioid-tolerant. Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in life-threatening respiratory depression. Alvogen Inc. has notified its distributors and customers by certified letter, and to date, has not received any reports of adverse events related to this issue.
In collaboration with the National Council of Behavioral Health (NCBH) and the American Pharmacist Association (APhA), Walgreens has launched a new program to help train pharmacists in identifying warning signs of mental health and substance use problems in their patients. The program created by the partnership is a 4-hour, interactive, online version of the Mental Health First Aid program, which was originally developed in 2001, to provide non-clinical individuals with strategies to help someone experiencing a mental health crisis. The NCBH plans to make the training available to any pharmacist industry wide, as it is estimated that 8 million U.S. adults are living with a mental health condition or opioid/substance addiction.
New Combination: Qternmet® XR (dapagliflozin/saxagliptin/metformin)
Oral tablets for the treatment of type 2 diabetes as adjunct to diet and exercise in adults [5/02/19 – ASTRAZENECA AB]
Novel Molecular Entity: Vyndaqel® (tafamidis meglumine)
Oral capsules for the treatment of heart disease caused by transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) in adults [5/3/19 – Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review – FOLDRX PHARMACEUTICALS INC]
New Formulation: Vyndamax™ (tafamidis)
Oral capsules for the treatment of heart disease caused by transthyretin-mediated amyloidosis cardiomyopathy (ATTR- CM) in adults [5/3/19 – Orphan Drug – FOLDRX PHARMACEUTICALS INC]
Indication: Bacterial infection
Dosage Form/Strength: 400MG capsules
Average Wholesale Price (AWP): Generic = 400MG ($249)/10 day supply | Brand = 400MG ($277)/10 day supply
Indication: Secondary prevention of cardiovascular and cerebrovascular events
Dosage Form/Strength: 81MG-40MG tablets
Average Wholesale Price (AWP): Generic = 81MG-40MG ($2,794) | Brand = 81MG-40MG ($40)