Higher Strength Eylea FDA Approved
On Aug. 18, 2023, Regeneron received approval from the U.S. Food and Drug Administration (FDA) for Eylea® HD (aflibercept) injection, 8mg. Like its lower-strength version, Eylea 2mg, it is indicated to treat wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). Eylea 2mg also is FDA-approved to treat macular edema following retinal vein occlusion (RVO) and retinopathy of prematurity (ROP), but Eylea HD is not. It blocks vascular endothelial growth factor (VEGF) to help prevent leaks from existing blood vessels in the eyes and to lower the growth rate of new ones. After a local anesthetic and an anti-infective are applied, it is administered as intravitreal (into the gel that fills the eyeballs) injections by specially trained doctors under sterile conditions in eye clinics or physicians’ offices. One dose of 8mg will be administered once a month for three months. Then dosing changes to one 8mg injection every eight to 16 weeks depending on the condition being treated and the patient’s response. The lower strength form of Eylea typically is given at four to eight-week intervals. Common side effects among patients in Eylea HD’s clinical trials included blurred vision, cataracts, floaters, irritation, pain increased pressure, and/or redness in the eyes. It was released for sale immediately at a wholesale acquisition cost (WAC) of $2,625 per dose. Here is the prescribing information for Eylea HD.
Ingrezza Receives Second FDA Indication
Ingrezza® (valbenazine – Neurocrine Biosciences) capsules were FDA approved on Aug. 18, 2023, to treat chorea (involuntary movement) that is associated with Huntington’s disease (HD). An inherited neurologic disease that affects about 40,000 Americans, HD primarily attacks the part of the brain that regulates behavior, mood, and movement. Usually diagnosed in adulthood, it causes progressive deterioration in the ability to move, reason, speak, and swallow. To treat chorea caused by HD, a 40mg initial daily dose of Ingrezza is used for the first two weeks of treatment. The recommended dose increases to 60mg per day for the following two weeks and then to the maintenance dose of 80mg per day. A vesicular monoamine transporter 2 (VMAT2) inhibitor, Ingrezza has been FDA-approved since 2017 for the treatment of adults who have tardive dyskinesia (TD). Similar to HD-related chorea, TD involves unmanageable, repetitive movements resulting from the use of some medications that interfere with dopamine activity in the brain. Ingrezza has a boxed warning that taking it may raise the risk of depression and suicidal thoughts/actions for patients who have HD. Two other VMAT2 inhibitors, Austedo™ (deutetrabenzine – Teva) and Xenazine® (tetrabenazine – Lundbeck, generics) already are FDA approved for treating chorea related to HD. Ingrezza’s revised prescribing information is here.
Approval for Maternal Use of Abrysvo
Under the FDA’s Breakthrough Therapy, Fast Track, and Priority Review pathways, Pfizer’s Abrysvo™ (respiratory syncytial virus [RSV] vaccine) solution was FDA approved on Aug. 21, 2023, for vaccinating women who are in late pregnancy. Vaccinating their mothers before babies are born helps to prevent lower respiratory tract disease (LRTD) caused by RSV during the first six months of life. Although it usually has only mild, cold-like symptoms, RSV can be quite serious and even life-threatening for newborns, whose immune systems are not yet fully developed. The Centers for Disease Control and Prevention (CDC) estimates that as many as 3% of babies who have RSV need hospital care each year. In a clinical study, the chance of an infant having severe LRTD due to RSV was 81.8% less during the first three months after birth and 69.4% less during the first six months for babies whose mothers were vaccinated. The recommended dose is one 0.5mL intramuscular (IM) injection during the 32nd week through the 36th week of gestation. Because the rates of preterm births and pregnancy complications, such as pre-eclampsia, were slightly higher among clinical trial participants who were vaccinated, the FDA has mandated further studies to determine whether the vaccine is the cause. A monoclonal antibody, Beyfortus™ (nirsevimab-alip) injection, was approved by the FDA in July 2023, to prevent LRTD caused by RSV for babies and toddlers. Also given as one IM dose, it is administered directly to babies born during or close to their first RSV season, and for children up to two years old who are at risk for severe RSV disease through their second RSV season. In May 2023, Abrysvo and another RSV vaccine, Arexvy (respiratory syncytial virus vaccine, adjuvanted – GSK) suspension, were FDA-approved to prevent RSV from causing LRTD for people who are at least 60 years old. Both vaccines work by keeping a part of RSV from changing shape to merge with body cells, keeping the virus more susceptible to immune activity. Look here for Abrysvo’s current prescribing information.