Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product

Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, Camber has not received any reports of adverse events related to this recall.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

Atovaquone Oral Suspension, USP was distributed nationwide to wholesalers, distributors, retail pharmacies, and mail order pharmacies.

The product is packaged in 210mL HDPE bottle in a mono carton. The identified NDC # associated with the product is 31722-629-21, UPC # 331722629218, and the affected lot# is E220182 with an expiration date of 12/2023.

No BeneCard PBF customers were effected by this recall.

Camber Pharmaceuticals, Inc. is notifying its distributors and customers by our Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.

Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.

Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email rxrecalls@inmar.com, Monday – Friday, 9am – 5pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-017

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Daybue™

FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

Acadia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first and only drug approved for the treatment of Rett syndrome.

Rett syndrome is a complex, rare, neurodevelopmental disorder typically caused by a genetic mutation on the MECP2 gene. It is characterized by a period of normal development until six to 18 months of age, followed by significant developmental regression with loss of acquired communication skills and purposeful hand use. Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. Rett syndrome is believed to affect 6,000 to 9,000 patients in the U.S.,with a diagnosed population of approximately 4,500 U.S. patients. Daybue is not recommended for patients with moderate or severe renal impairment.

Daybue™ is expected to be available in the U.S. by the end of April, 2023.

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Zavzpret

Pfizer Inc. has announced the U.S. Food and Drug Administration (FDA) has approved Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. There are several other CGRP antagonists currently on the market — some for acute treatment of migraine, others for migraine prevention, and some can be used for both. (i.e. injectables: ajovy, aimovig, emgality, vyepti oral: qulipta, ubrelvy, and nurtec).

In its pivotal Phase 3 study, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo.

The FDA approval is based on two pivotal randomized, double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profiles of Zavzpret for the acute treatment of migraine. In these studies, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom (defined as a reduction of moderate or severe headache pain to no headache pain) and freedom from most bothersome symptom at two hours post-dose (defined as the absence of the selfidentified most bothersome symptom).

Zavzpret is contraindicated in patients with a history of hypersensitivity to zavegepant or to any of its components. Hypersensitivity reactions, including facial swelling and urticaria, have occurred with Zavzpret in clinical studies.

Zavzpret is anticipated to be available in pharmacies in July 2023.

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Researchers announce highly accurate blood test for Alzheimer’s Disease

A team of researchers from Rowan-Virtua School of Osteopathic Medicine (RowanVirtua SOM) and Durin Technologies, Inc., have announced the results of a newly-designed blood test that can detect the presence of Alzheimer’s disease-related pathology up to 10 years before symptoms arise with a nearly 97 percent accuracy rate. Their findings appear online ahead of press in the Journal of Alzheimer’s Disease.

The study involved 328 blood samples with the goal of determining if a test that monitors a small number of a patient’s autoantibodies can detect Alzheimer’s disease (AD)-related pathology at presymptomatic, prodromal (i.e., mild cognitive impairment), and mild-moderate stages of the disease.

The research team showed that their test, using just eight autoantibody biomarkers, could accurately identify the presence of Alzheimer’s disease pathology across the disease’s progression, including among those originally determined to have no trace of the disease.

For a number of reasons, the test has significant potential to impact effective treatments for Alzheimer’s disease. The test is minimally invasive and inexpensive, it can diagnose or predict clinical decline in asymptomatic individuals, and it can monitor a patient’s progress while under treatment, making it ideal for use in clinical trials and in frontline and community primary care settings, including those in rural and economically disadvantaged regions.

The researchers noted that the use of autoantibodies as blood-based biomarkers is particularly exciting because it enables development of a platform technology for early detection of multiple diseases.

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Rezvoglar Price Announced

Eli Lilly announced the price of Rezvoglar (insulin glargine-aglr) as well as price cuts on other insulin products and a cap on out-of-pocket (OOP) costs for insulin. Lilly’s announcement was not unexpected, based on recent publicity and legislation regarding drug prices, particularly with respect to insulin.

In today’s announcement, Lilly stated that a five-pack of KwikPens will be priced at $92, which is a 78% discount to Sanofi’s Lantus (insulin glargine). This price will be effective starting on April 1, 2023.

Rezvoglar was approved as the second interchangeable biosimilar to Lantus on November 17, 2022.
Biocon’s Semglee was approved as the first interchangeable biosimilar to Lantus, and Biocon launched
both branded and unbranded versions.

Once Rezvoglar launches, patients can receive Rezvoglar or Semglee (branded or unbranded) at the pharmacy in place of branded or unbranded Lantus. Rezvoglar’s label does not specify whether it is interchangeable with Semglee, only that it is interchangeable with Lantus.

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