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Pulse Newsletter

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

Volume 4 | Issue 18
September 15, 2022

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Xenpozyme™, The First Treatment for Acid Sphingomyelinase Deficiency

On August 31, 2022, the U.S. Food and Drug Administration (FDA) approved Xenpozyme™ (olipudase alfa) for the treatment of Acid Sphingomyelinase Deficiency (ASMD) in pediatric and adult patients. ASMD is a rare genetic disorder that results in an accumulation of sphingomyelin, a fatty substance, in a variety of tissues including the spleen, lungs, liver and brain. The disease can present in varying levels of severity and age of onset. In mild cases, a patient may only have minimal neurological symptoms and survive into adulthood. In contrast, severe cases can present in infancy and are often fatal at a young age. Xenpozyme™ is an enzyme replacement therapy that reduces the accumulation of sphingomyelin in the body tissues of patients. Xenpozyme™ was studied in 31 patients, and it was effective in reducing liver and spleen size and improving lung function compared to placebo. The medication was granted orphan drug designation by the FDA, a status that encourages development of medications for serious rare diseases.

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Drug Safety

FDA Alerts MS Patients of Risk of Missed Dose Due to Incompatible Autoinjector Devices 

On August 18, 2022, the FDA alerted patients and health care providers of cross-compatibility issues with autoinjector devices and associated glatiramer acetate injections. Use of an incompatible autoinjector with this medication may prevent some or all of the dose from being administered. Glatiramer acetate is a medication used in the treatment of multiple sclerosis, and partial or missed doses may lead to decreased protection from relapses. Glatiramer acetate is available in three different FDA-approved single-dose prefilled syringes. Patients have the option of administering the medication by holding the syringe in their hand or by inserting the syringe into an autoinjector for better control. These autoinjectors are reusable and often used by patients whose dexterity has been affected by their multiple sclerosis. The FDA has alerted drug manufacturers to instruct patients to verify the compatibility of their glatiramer acetate and autoinjector each time they receive a new prescription. Patients can verify this through their health care provider or the drug manufacturer’s website. Adverse events from this incompatibility should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

CDC Updates Influenza Vaccine Recommendations for 2022-23 Season  

On August 26, 2022, the CDC released updated immunization recommendations for the 2022-23 influenza season. Annual influenza vaccines are recommended for all individuals 6 months and older, and most adults should receive a single dose of the vaccine during September or October of this year. The peak of influenza season cannot be predicted each year, but it can be as early as October. Receiving the vaccination in September or October provides optimal protection for individuals against severe illness and preempts transmission of the influenza virus in the community. Some children aged 6 months to 8 years require 2 doses of the vaccine and should receive their first dose as soon as possible to allow full vaccination by October. There are no recommendations for anyone to receive booster doses later in the influenza season. The available vaccines this season are all quadrivalent products that protect against four different influenza viruses.  It is recommended that older adults (≥65 years) receive higher dose or adjuvanted (a vaccine that contains an ingredient which creates a stronger immune response) influenza vaccines. It is anticipated that the COVID-19 virus will continue to circulate during the influenza season, so it is also recommended that patients stay up to date on their COVID-19 vaccinations and booster doses. The CDC has determined that, based on currently available data, coadministration of the influenza and COVID-19 vaccines is safe and effective for patients who wish to get both during the same visit to their healthcare provider. 

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Spevigo® (spesolimab-sbzo)

Intravenous infusion approved for the treatment of generalized pustular psoriasis flares in adult patients. [09/01/2022 – Orphan Drug – BOEHRINGER INGELHEIM PHARMACEUTICALS, INC]

New Formulation: Konvomep™ (acalabrutinib)

Oral suspension approved for the short-term treatment of active benign gastric ulcers (4-8 weeks) and the reduction of risk of gastrointestinal bleeding in critically ill patients. [08/30/2022 – AZURITY PHARMACEUTICALS, INC.]