FDA approves new migraine treatment
On Oct. 10, 2019, the U.S. Food and Drug Administration (FDA) approved Reyvow® (lasmiditan) oral tablets for the short-term treatment of migraine in adults with or without aura (a sensory disturbance/phenomenon). Migraine headaches are a type of headache characterized by intense throbbing or pulsing pain of the head and is often associated with nausea and sensitivity to light and/or sound. In clinical trials involving 3,177 participants, a significantly higher percentage of patients achieved pain relief or resolution of their most bothersome symptom (nausea, light sensitivity, or sound sensitivity) at two hours post treatment with Reyvow® compared to placebo. Although Reyvow® is not approved for the prevention of migraine, the approval gives patients a new option for acute migraine treatment, which is thought to affect roughly one out of every seven Americans.
Low vaccination rates among pregnant women may leave mothers and their newborns susceptible
Current Center for Disease Control (CDC) pregnancy vaccination guidelines recommend the influenza and pertussis vaccines be given as a preventative measure to reduce the risks of the two diseases for the mother and baby. According to a new report released on Oct. 8, 2019, a majority of pregnant women in the U.S. have not received both vaccines. The new report details the results of a CDC survey of more than 2,000 women aged 18-49 years old who were pregnant between August 2018 and April 2019. The survey found that 54% of respondents reported getting an influenza vaccination before or during pregnancy and 55% reported receiving pertussis vaccination (Tdap) during pregnancy, but only 35% reported getting both vaccines. The CDC press release emphasizes that receiving both vaccinations has been shown to decrease the risk of hospitalizations and deaths associated with these diseases in both mothers and their newborns.
From the Industry
New analysis suggests benefit of adding ticagrelor or clopidogrel to aspirin after cardiac surgery
The new systematic review and meta-analysis published in the BMJ, set out to assess the effects of different blood thinners on the ability to prevent vein graft failure (VGF) after coronary artery bypass grafting (CABG), a procedure used to redirect blood flow to the heart. VGF occurs when a grafted vein supplying blood to the heart becomes blocked, which can result in heart attack and death. The analysis evaluated data from 20 randomized trials that investigated nine different interventions (eight active and one placebo) and comprised 4,803 patients. The study concluded that dual antiplatelet therapy (aspirin plus ticagrelor or aspirin plus clopidogrel) was more effective than aspirin alone in preventing VGF after CABG. The analysis helps fill in knowledge gaps surrounding therapeutic benefits of adding additional therapies to aspirin after CABG.
Recent FDA Approvals
New Drug Approval: Aklief ™ (trifarotene)
Topical cream for the treatment of acne in patients nine years of age and older [10/4/2019 – GALDERMA RESEARCH AND DEV INC]
Novel Drug Approval: Beovu® (brolucizumab-dbll)
Injectable solution for the treatment of a specific type of degenerative eye disease, known as wet macular degeneration [10/7/2019 – NOVARTIS PHARMS CORP]
Novel Drug Approval: Scenesse® (afamelanotide)
Subcutaneous implant for the treatment of a rare skin disorder, known as erythropoietic protoporphyria [10/8/2019 – Orphan Drug; Priority Review – CLINUVEL INC]
New Generics Entering the Marketplace
Dutoprol® (metoprolol succinate/hydrochlorothiazide)
Indication: High blood pressure
Dosage Form/Strength: 25-12.5MG Tablet
Average Wholesale Price (AWP)*: Generic = $1,646 | Brand = $263
Dosage Form/Strength: 1% Cream
Average Wholesale Price (AWP)*: Generic = $432 | Brand = $459