Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
Highlights
- FDA grants Emergency Use Authorization for third COVID-19 vaccine
- Merck partners with Johnson & Johnson to manufacture COVID-19 vaccines
- Manufacturers of Plavix (clopidogrel) ordered to pay $834 million to state of Hawaii
- FiercePharma summarizes the year's top 10 most anticipated drug launches
- Semaglutide produces significant weight loss among non-diabetic patients in phase 3 trial
FDA Approvals and Launches
- Evkeeza (evinacumab-dgnb) is approved to treat a rare form of high cholesterol.
- Entresto (sacubitril/valsartan) receives additional indication to treat patients with heart failure with either reduced or preserved ejection fraction.
- Nulibry (fosdenopterin) is approved to treat molybdenum cofactor deficiency, a rare genetic disorder.
- Amondys 45 (casimersen) is approved to treat Duchenne muscular dystrophy.
- Azstarys (serdexmethylphenidate/dexmethylphenidate) is approved to treat attention deficit hyperactivity disorder.
News
FDA grants Emergency Use Authorization for third COVID-19 vaccine
- Janssen, a company owned by Johnson & Johnson, is the manufacturer of the vaccine.
- In contrast to the other available COVID-19 vaccines, this vaccine requires one dose and was found to be approximately 67% effective in preventing moderate to severe/critical disease occurring at least 14 days after vaccination.
Merck partners with Johnson & Johnson to manufacture COVID-19 vaccines
- Merck discontinued the development of its own proprietary vaccine candidate in January due to unsuccessful clinical trial results.
- Johnson & Johnson expects the arrangement to significantly expand its capacity for vaccine production.
Manufacturers of Plavix (clopidogrel) ordered to pay $834 million to state of Hawaii
- The judgment was a result of the complaint that the manufacturers failed to warn prescribers and patients that the medication had a diminished or non-existent effect in certain populations.
- An FDA Black Box Warning was added to the product labeling 12 years after the product launched.
FiercePharma summarizes the year's top 10 most anticipated drug launches
- This year's list includes investigational Alzheimer's drug aducanumab and cholesterol drug inclisiran.
PhRMA publishes "Follow the Dollar Part II: Understanding the Cost of Brand Medicines Administered to Commercially Insured Patients in Hospital Outpatient Departments"
- The report explains the financial flow of funds for prescription drug dispensing at hospital outpatient departments.
- The authors found that drugs dispensed in this setting result in higher costs for commercial health plans due to hospitals setting higher markups and cite references that found no corresponding increases in quality of care.
Health Action Council and UnitedHealthcare publish "Finding the uncommon: Revealing disparities in care and prescribing for common conditions"
- The report describes demographic trends as they relate to five common conditions: asthma, back disorders, diabetes, hypertension, and mental health/substance abuse.
- Findings suggest companies that implement deliberate strategies around their employees' most common chronic health conditions may improve overall employee health and yield cost savings over the long term.
Institute for Clinical and Economic Review (ICER) publishes "Unsupported Price Increase Report"
- The authors spotlighted seven drugs with price increases unsupported by new clinical evidence.
- Enbrel (etanercept) was found to be the drug most responsible for an increase in drug spend due to net price change.
Clinical Trials
Semaglutide produces significant weight loss among non-diabetic patients in phase 3 trial
- The trial found an estimated difference in body weight of 12.4% between treatment and placebo group.
- Semaglutide is currently available as a diabetes treatment under the brand names Rybelsus (oral) and Ozempic (injectable).
Pfizer and BioNTech begin studying the effectiveness of a booster dose of COVID-19 vaccine
- The vaccine is currently given in a two-shot series; the booster dose would be a third dose given 6-12 months after the initial series.
- The study will evaluate the effectiveness of the vaccine against new variants of COVID-19 that have emerged.
Baricitinib demonstrates effectiveness in treating alopecia areata in phase 3 trial
- The drug is approved under the brand name Olumiant for the treatment of rheumatoid arthritis.
- There are no currently approved treatments for alopecia areata.