Your source for the latest industry trends and drug information news.
Volume 4 | Issue 10
May 15, 2022
Contributors:
Chief Authors: Bonnie Broczkowski & Colleen Peehler
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On May 5, 2022, the U.S. Food and Drug Administration (FDA) issued limitations on Janssen COVID-19 Vaccine to be used only for adults who are unable to access or who would not otherwise receive an authorized or approved COVID-19 vaccine including Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY) and Moderna COVID-19 Vaccine (Spikevax). For individuals who elect to receive the Janssen COVID-19 Vaccine, it is authorized as a single primary vaccination dose and as a single booster dose at least two months after completing primary vaccination with Janssen COVID-19 Vaccine or a different COVID-19 vaccine. The FDA authorized emergency use of Janssen COVID-19 Vaccine for adult patients on February 27, 2021. The limitations were recently imposed after evaluating the risk of thrombosis with thrombocytopenia syndrome (TTS) associated with administration of the Janssen COVID-19 Vaccine. TTS is a rare but potentially life-threatening syndrome resulting in blood clots and low levels of blood platelets that have been reported in patients within two weeks following administration of the Janssen COVID-19 Vaccine. Symptoms of thrombosis, or blood clots, may include severe headaches, vomiting, visual impairment, or pain and swelling in limbs. Symptoms of thrombocytopenia, or low platelets, may include bruising and round purple spots on the skin due to bleeding.
On April 27, 2022, Novo Nordisk published an update on the Wegovy™ (semaglutide) shortage. Wegovy™ is indicated for chronic weight management approved by the FDA in June 2021. It is a once-weekly, under-the-skin injection for adult patients who are obese or overweight with one or more weight-related conditions, such as high blood pressure or Type 2 Diabetes. Wegovy™ works by mimicking a hormone that regulates appetite and food intake. Wegovy™ was the first new weight management medication approved since 2014, sparking significant interest from the health care community and patients, resulting in unprecedented demand for the drug. In December 2021, the contract manufacturing site of Wegovy™ halted syringe filling deliveries due to issues with good manufacturing practices, causing supply to fall short of demand. As the shortage continues, Novo emphasizes that the goal is to make sure those patients who already initiated treatment can continue therapy. Novo has asked providers not to start treatment for new patients, paused new Wegovy™ sales initiatives and reduced supply for the first two dose strengths (0.25 mg and 0.5 mg). Novo reports that production is back on track and expects that all Wegovy™ doses will be available during the second half of 2022, but since new prescriptions continue to occur despite current measures, Novo will reduce or stop supply of 1 mg dose strength starting in May so that supply can be stabilized.
On May 2, 2022, Supernus Pharmaceuticals, Inc. announced the expanded FDA approval of Qelbree® (viloxazine) extended-release capsules for the treatment of attention deficit hyperactivity disorder (ADHD) to adult and pediatric patients over 6 years old. Qelbree was first approved for the treatment of ADHD in pediatric patients 6-17 years old in April 2021. ADHD is a brain development disorder characterized by inattention and/or hyperactivity or impulsivity. Conventional treatment of ADHD includes behavioral therapy and medications such as stimulants and non-stimulants. Stimulants such as methylphenidate and amphetamines increase the levels of chemicals in the brain that help with attention. Nonstimulants such as atomoxetine and guanfacine are alternative therapies when patients do not respond to stimulants. It has been 20 years since the last nonstimulant treatment option for adults with ADHD was approved. This approval was granted after evaluating the efficacy and safety data of Qelbree® in adults with ADHD. Participants who received daily dose of Qelbree® had a significant ADHD symptom score reduction compared to the placebo group and no evidence of abuse, which is a concern when stimulants are used for ADHD. The most common adverse reactions to Qelbree® were insomnia, headache, drowsiness, fatigue, nausea, and decreased appetite.
Novel Drug Approval: Vivjoa™ (oteseconazole)
Oral capsules approved to reduce incidences of recurrent vulvovaginal candidiasis (RVVC), a type of chronic yeast infection, in female patients who are not able to have children (due to the long duration the medication stays in the body and the fetal harm it can cause). [04/26/2022 – Priority Review – MYCOVIA PHARMACEUTICALS INC]
New Dosage Form: Camzyos™ (mavacamten)
Oral capsules approved for the treatment of certain classes of symptomatic obstructive hypertrophic cardiomyopathy (HCM) in adult patients. HCM is a heart disease in which the muscles of the heart thicken leading to difficulties with pumping blood. [04/28/2022 – Orphan Drug – MYOKARDIA INC]
Esbriet® (pirfenidone)
Indication: Used for the treatment of idiopathic pulmonary fibrosis (IPF) which is a lung disease characterized by scarring of the lungs.
Dosage Form/Strength: 801 MG Tablets
Average Wholesale Price (AWP): Generic = $11,413.22 | Brand = $12,539.32
