Pulse Newsletter | Volume 8 - Issue 11

FDA Approves New Drug to Treat Parkinson’s Disease in Adults

On September 25, 2026, the U.S. Food and Drug Administration (FDA) approved Juvmo^™  (tavapadon) tablets for the treatment of adult patients with Parkinson’s disease. Parkinson’s disease is a chronic, progressive disease affecting the brain and nervous system that causes tremors, along with stiffness and difficulty with movement and balance. Juvmo^™ is available as 0.25mg, 1mg, 5mg, 10mg and 15mg tablets. The dose of Juvmo^™ is initially titrated, meaning the lowest dose (0.25mg per day with or without food) is started then gradually increased over 40 days. The recommended initial maintenance dose of 5mg begins on day 41. The maximum recommended maintenance dose is 15mg once a day, based on the patient’s clinical response and tolerability to the medication.

The safety and efficacy of Juvmo^™ was evaluated in two randomized, double-blind, multicenter, placebo-controlled clinical trials. Efficacy was determined by the change from baseline in the patient’s activities of daily living, as measured by a questionnaire. Patients treated with Juvmo^™ had a statistically significant improvement in their activities of daily living compared to patients taking placebo. Warnings and precautions of Juvmo^™ include risk of low blood pressure, problems with impulse control, hallucinations and uncontrolled muscle movements. The most common side effects associated with Juvmo^™ are nausea, headache, dizziness, fatigue, altered taste perception, vomiting, dry mouth and anxiety. Patients should let their health care provider know what other medications they are taking, including other prescription and over the counter (OTC) products, as certain types of drugs may interact with Juvmo^™ or affect how Juvmo^™ works in the body. Juvmo^™ is available in the U.S. market, and the list price is $4,900 per month.

FDA Approves New Safe and Effective OTC Eye Drop

On October 16, 2026, the FDA approved a new over the counter eye drop, Brytly^® (apraclonidine) 0.125% ophthalmic solution for temporary relief of eye redness due to minor irritations in adult and pediatric patients ages 12 years and older. Brytly^® is the first FDA-approved OTC eye drop containing apraclonidine as the active ingredient. According to the FDA, increasing the amount of safe and affordable OTC options for patients is a priority and helps expand healthcare access to patients. There are prescription eye drops currently available that contain higher concentrations (0.5%, 1%) of apraclonidine as the active ingredient, used for the short-term treatment of lowering intraocular pressure in adult patients with glaucoma and in adult patients to prevent increased intraocular pressure after surgery.

Brytly^® is recommended to be used once a day in the affected eye and should not be used more than twice a day. The onset of effect of Brytly^® occurs quickly and may last up to 12 hours. Patients should remove their contact lenses prior to using Brytly^® and wait at least 10 minutes after using Brytly^® before re-inserting their contact lenses. If patients use other eye drops, they should wait at least 5 minutes between each product. Patients are advised to stop using Brytly® if they experience eye pain, vision changes or persistent eye redness or irritation (lasting more than 3 days). Brytly^® is not yet available in the U.S. but is expected to be available to purchase online and in retail stores in the coming months according to the manufacturer. Pricing information for Brytly^® is not yet available.

FDA Approves Pioneering New Drug for Chronic Hepatitis B Treatment

On October 20, 2026, the FDA approved Hibsago (bepirovirsen) subcutaneous injection for the treatment of chronic hepatitis B virus (HBV) infection in adult patients who have been on nucleoside-analog reverse transcriptase inhibitor (NrtI) therapy for at least six months and have a confirmed low level of HBV. The recommended dose of Hibsago is 300mg (two 150mg injections given under the skin) twice a week (doses should be 3 or 4 days apart) for weeks 1 and 2, then 300mg once a week (administered on the same day each week) for weeks 3 to 24. The injection site should be rotated for each dose. During the 24-week therapy with Hibsago, patients should continue taking their NrtI therapy. Upon completion of the 24-week therapy course with Hibsago, patients should remain on their NrtI therapy for at least another 24 weeks. After that additional 24-weeks of NrtI therapy is completed, patients may be evaluated by their health care provider to determine if NrtI therapy can be discontinued.

The package labeling contains a boxed warning, the most serious safety warning, for risk of hepatic flares (can cause a dangerous increase in liver enzymes) and life-threatening thrombocytopenia (a sudden and dangerous decline in platelet count, which can increase risk of bleeding). Treatment with Hibsago is contraindicated in patients with liver impairment or liver cirrhosis with liver impairment, as well as patients with a low platelet count. Warnings and precautions of Hibsago include worsening kidney function and serious immune system reactions. Patients with hepatitis D should not take Hibsago. The most common side effects associated with Hibsago are injection site reactions, increased body temperature, headache and fatigue. Hibsago is not yet available in the U.S. market, and the list price has not been announced.

New FDA Approvals

New Drug: Emcitate^® (tiratricol)

Tablets for oral suspension approved for the treatment of peripheral thyrotoxicosis (excessive thyroid hormone) in adult and pediatric patients with a specific type of genetic mutation. [9/28/2026 – Rare Thyroid Therapeutics International]

New Generics Entering the Marketplace

Adempas^® (riociguat)

Indication: For the treatment pulmonary hypertension (high blood pressure in the arteries of the lungs) in adults

Dosage Form/Strength: 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg tablets

Average Wholesale Price (AWP): Generic = $16,000/month | Brand = $17,800/month