Drug and Device Approvals: Deep Brain Stimulation Therapy for PD; generic Xarelto; neffy nasal epinephrine spray; Odactra for dust mite allergies; Encelto for rare eye disease
Deep Brain Stimulation Therapy for Parkinson’s Disease
The FDA approved an adaptive version of Medtronic's Deep Brain Stimulation Therapy System, an implantable device that delivers personalized, low-intensity electrical pulses to nerve centers in the brain as part of deep brain stimulator (DBS) therapy for Parkinson’s Disease (PD). The user will now have an option for adaptive deep brain stimulation (aDBS), which individualizes the DBS therapy by adjusting the stimulation level based on detected brain signals surrounding the DBS electrode of the implant. This option is intended to reduce some of the symptoms for patients whose PD symptoms have not been adequately controlled with medicine for at least four years.
According to Fierce Biotech, "The company said its U.S. rollout represents the largest-ever commercial launch of a brain-computer interface technology, with Medtronic’s BrainSense platform reading changes in a patient’s neural activity in real-time and then adjusting therapy to suit." The device is like a pacemaker for the brain.
Fierce Biotech: "FDA approves Medtronics Adaptive Deep Brain Stimulation Therapy"
First generics of Xarelto approved
The FDA approved the first two generic versions of low-dose (2.5 mg) Xarelto (rivaroxaban). Johnson & Johnson's Xarelto is an anticoagulant (blood thinner) used to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of blood clotting events like deep vein thrombosis (DVT) or pulmonary embolism (PE). The Xarelto generics will be made by Lupin and Taro. Xarelto was one of ten brand name drugs selected by Medicare about six months ago for price negotiation.
Xarelto patient ratings and reviews at AskaPatient website
Neffy epinephrine nasal spray: new lower dosage for young children
The FDA approved ARS Pharma's 1 mg formulation of neffy (epinephrine) nasal spray for patients age four and up. Neffy treats emergency allergic reactions, including anaphylaxis. The new dosage product is approved for patients weighing at least 15 kg (33 pounds) and less than 30 kg (66 pounds).
In a clinical trial of pediatric patients in this weight range, the most common adverse reactions were nasal congestion (19%), upper respiratory tract congestion (14%), dry throat (10%), nasal dryness (10%), and paresthesia (10%). Paresenthesia is a prickling or "pins and needles" skin sensation. At room temperature, neffy has a shelf life of 24 months. This formulation is expected to be available in May 2025. Neffy 2 mg formulation was originally approved in August 2024.
FDA Press Release
Odactra Approved for Pediatric Use for Dust Mite Allergies
The FDA approved Merck's Odactra (Dermatophagoides farinae and Dermatophagoides pteronyssinus) allergen extract for patients 5 through 11 years of age to treat nasal inflammation caused by house dust mite allergies, with or without eye inflammation (conjunctivitis). The FDA press release explains that house dust mite allergies are a reaction to tiny bugs that are commonly found in house dust. Dust mites, close relatives of ticks and spiders, are too small to be seen without a microscope. They are found in bedding, upholstered furniture and carpeting.
Individuals with house dust mite allergies may experience a cough, runny nose, nasal itching, nasal congestion, sneezing, and itchy and watery eyes. Odactra is an allergen extract immunotherapy that is administered under the tongue (sublingual). The drug has a boxed warning to inform that Odactra can cause severe allergic reactions that may be life-threatening. As with other FDA-approved allergen extracts administered sublingually, patients receiving Odactra should also be prescribed auto-injectable epinephrine. Odactra has been approved for adults since 2017.
https://www.pharmacytimes.com/view/fda-approves-odactra-label-expansion-to-include-children-with-house-dust-mite-allergy
Encelto (revakinagene taroretcel-lwey) cell therapy
The FDA approved Neurotech Pharma's cell therapy Encelto to treat idiopathic macular telangiectasia type 2 (MacTel), a rare eye disease leading to progressive and irreversible sight loss. A medication-containing device is surgically implanted by a qualified ophthalmologist. Encelto is an intravitreal implant, which allows for medication to be released in the back of the eye, where light-detecting cells called photoreceptors are located. The FDA maintains a list of all cell and gene therapy approvals.
https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025
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