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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 16
September 15, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Biosimilar for Treatment of Multiple Sclerosis

On August 24, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of Tyruko® (natalizumab-sztn), the first biosimilar product approved for the treatment of relapsing forms of multiple sclerosis (MS). MS is an autoimmune disease that damages myelin, the protective layer on nerve fibers. Loss of this layer disrupts the conduction of signals between the brain and the rest of the body, leading to symptoms such as tingling, numbness, pain, fatigue, memory problems, changes in vision and movement difficulties. The most common disease course for patients with MS is relapsing-remitting disease, characterized by episodes of worsening function followed by periods of recovery. As their disease progresses, these patients may have more limited remission periods, leading to increased disability.

Tyruko® is a biosimilar product of Tysabri® (natalizumab) injection, which was approved in 2004. Both products are approved to treat the first occurrence of MS symptoms, relapsing-remitting disease and active secondary progressive disease (gradual worsening of disease following a relapsing-remitting course). The approval of Tyruko® will increase accessibility of this treatment option for patients with MS at a potentially lower cost.  Also, like Tysabri, Tyruko has received approval to treat moderately to severely active Chron’s disease in patients who do not respond to conventional therapies.

Biosimilar products must meet rigorous FDA approval standards to ensure that there are no clinically meaningful differences in safety and efficacy when compared to the original product. Both products contain a warning informing patients and health care professionals to the risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that could lead to severe disability or death. Long duration of treatment and prior use of immunosuppressant medications could increase a patient’s risk of PML. Patients receiving these treatments must be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program, where prescribers evaluate patients approximately every six months after initiating and discontinuing treatment.  

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Drug Safety

FDA Announces Voluntary Nationwide Recall of Dr. Berne’s Eye Drops Due to Contamination

Dr. Berne’s Whole Health Products announced a voluntary recall of eye drops and solutions on August 26th due to bacterial and fungal contamination. One lot of MSM DROPS 5% was found to be contaminated with bacteria and fungus, prompting Dr. Berne’s to recall additional products out of caution. The recall includes all lots of Organic Castor Oil Eye Drops, MSM MIST 15% solution, and MSM DROPS 5% and 15% solution. Use of contaminated eye drops could result in serious infection, potentially leading to blindness or progressing to a life-threatening illness. Consumers and distributors are being notified of this recall by email. As of the date of the recall, there have been 2 reports of adverse events related to this recall.  Customers experiencing any problems following the use of these products are encouraged to contact their health care provider and to report the problems to the FDA’s MedWatch Adverse Event Reporting program

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From the Pharmaceutical Industry

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

On August 21, 2023, the FDA announced its approval of the vaccine Abrysvo™ for use in pregnant individuals. This is the first vaccine approved for use at 32 through 36 weeks' gestation to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. Abrysvo™ was previously approved in May 2023 for use in people at least 60 years of age.  RSV is a common respiratory virus that may cause mild, cold-like symptoms in infected individuals. Infants are at an increased risk of severe RSV infection that may lead to lower respiratory tract diseases, such as pneumonia or bronchiolitis, that could result in hospitalization. The risk of RSV-associated LRTD is the highest during the first year of life according to the Centers for Disease Control and Prevention (CDC).

The safety and efficacy of Abrysvo™ is based on ongoing, randomized, placebo-controlled clinical studies. In one of these clinical studies, approximately 3,500 pregnant individuals received the Abrysvo™ vaccine. Abrysvo™ reduced the risk of severe LRTD in infants by 81.8% within 90 days after birth and by 69.4% within 180 days after birth. The vaccine’s greatest impact was observed when administered to pregnant participants between 32 through 36 weeks' gestation. Two additional studies of Abrysvo™ reviewed approximately 3,600 pregnant individuals for the safety of the vaccine. The most reported side effects include pain at injection site, headache, muscle pain and nausea. Low birth weight and jaundice in infants were reported more frequently with Abrysvo™ than with placebo, as were pre-eclampsia and preterm birth. The FDA is requiring post-marketing studies to assess the risk of preterm birth and hypertension disorders of pregnancy, including pre-eclampsia. Abrysvo™ was granted Priority Review, Fast Track and Breakthrough Therapy designations.

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FDA Approvals

New FDA Approvals

New Drug: SohonosTM (palovarotene)

Capsules approved for the reduction in extra-skeletal bone formation in females 8 years or older and males 10 years or older with fibrodysplasia ossificans progressiva, a rare genetic condition where bone gradually replaces muscles and connective tissue. [08/16/23 - IPSEN INC]

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New Generics

New Generics Entering the Marketplace

VYVANSE® (lisdexamfetamine dimesylate)

Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) 

Dosage Form/Strength: 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg oral capsules

Average Wholesale Price (AWP): Generic = $198 | Brand = $443