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Pulse Newsletter

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

Volume 6 | Issue 9
May 1, 2024

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

Clinical Pharmacy Update

FDA Approves Winrevair™ as Injectable Treatment for Pulmonary Arterial Hypertension

On March 26, 2024, the U.S. Food and Drug Administration (FDA) approved Winrevair™ (sotatercept-csrk), the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) in adults. PAH is a type of high blood pressure that affects arteries in the lungs and the right side of the heart. As the disease progresses, the small arteries in the lungs become narrowed and blocked, leading to increased pressure in the pulmonary arteries, heart failure and ultimately death if not treated. PAH is more frequent in women ages 30-60 and in those with a family history of the disease. Winrevair™ works by regulating the number of new cells that grow in the arterial walls, thereby reducing the narrowing that causes the progression of PAH. Results of the STELLAR clinical trial showed that adding treatment with Winrevair™ to standard therapy significantly improved exercise capacity and reduced the occurrence of death or PAH clinical worsening events by 84%, compared to the addition of placebo. The most common side effects included headache, nose bleeds, rash, dizziness, diarrhea and redness of skin. The drug should be stopped if patients develop signs or symptoms of serious bleeding. Winrevair™ is injected under the skin every three weeks. It is intended for use under the guidance of a health care professional, but patients can self-administer the drug when considered appropriate, following training and planned follow-up. 

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Drug Safety

Otsuka Initiates Voluntary Nationwide Recall of Abilify® (aripiprazole) Tablets

On April 9, 2024, Otsuka America Pharmaceutical, Inc. announced a voluntary recall of certain Abilify® (aripiprazole) Tablets in the United States due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient manufactured on the same equipment. Dosage forms affected include 5 mg, 10 mg, 15 mg and 30 mg tablets. Based on sample testing, contamination was determined to be below the threshold for posing material patient risk. Abilify® is indicated to treat schizophrenia and mania associated with bipolar disorder. Generic versions of Abilify® are available that are not impacted by this recall. There have been no adverse events related to this recall to date, and even though it’s not anticipated, patients should reach out to their health care provider if any problems arise from use of this product. Adverse effects may also be reported to the FDA’s MedWatch Adverse Event Reporting program

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From the Pharmaceutical Industry

FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy

On March 18, 2024, the FDA approved Lenmeldy™ (atidarsagene autotemcel) for the treatment of metachromatic leukodystrophy (MLD) in children. MLD is a rare genetic disorder affecting the brain and nervous system. It is caused by a deficiency in an enzyme that breaks down fatty substances, allowing them to build up in cells of the brain, spinal cord and nerves. This buildup damages the protective covering of the cells and leads to loss of motor and cognitive function and early death. Lenmeldy™ is the first gene therapy approved to treat MLD. It is intended for use in children who are pre-symptomatic or are early in their symptomatology to mitigate permanent damage to the nervous system and slow disease progression. The safety and effectiveness of Lenmeldy™ was demonstrated in clinical trials comparing patients treated with Lenmeldy™ versus placebo. Patients in the Lenmeldy™ group showed significantly reduced risk of severe motor impairment or death compared to placebo. Common side effects include fever, low white blood cell count, mouth sores, infections, enlarged liver and rash. Lenmeldy™ was granted priority review, orphan drug, rare pediatric disease and regenerative medicine advanced therapy designations.

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FDA Approvals

New FDA Approvals

New Drug: Zevtera® (ceftobiprole medocaril)

Intravenous injection indicated for adult patients with acute bacterial skin infections or Staphylococcus aureus in the bloodstream and for adult and pediatric patients 3 months and older with community-acquired bacterial pneumonia (CABP). [4/3/24 - BASILEA PHARM]

New Drug: Lumisight™ (pegulicianine)

Intravenous injection to be used in fluorescence imaging during lumpectomy surgery in adults with breast cancer, following the removal of the primary tumor, to assist in the detection of cancerous tissue in the surrounding area. [4/17/24 - LUMICELL INC]