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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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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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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Reata Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, has received approval from the U.S. Food and Drug Administration for Skyclarys™ (omaveloxolone) as a treatment for Friedreich’s ataxia in adults and adolescents aged 16 years and older.

Friedreich’s ataxia is an ultra-rare, inherited neurodegenerative disorder that is typically diagnosed during adolescence and affects approximately 5,000 patients in the U.S. With this approval, the FDA granted a rare pediatric disease priority review voucher. The WAC Cost for a one-month supply is noted at $370,000.

Skyclarys™, an oral once-daily medication that has received Orphan Drug designation, is also under review in Europe by the European Medicines Agency (EMA).

Treatment with Skyclarys can cause an elevation in hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. Skyclarys can cause changes in cholesterol and increases in B-type natriuretic peptide (BNP), a marker of cardiac function.

Women are advised not to breastfeed during treatment with Skyclarys.

Anticipated commercial drug supply of Skyclarys will be available in the second quarter of 2023.

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Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility.

Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.

To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product.

Product was distributed worldwide by Purely Soothing LLC via online e-commerce and trade shows (Ex. Amazon Marketplace, etc.).

The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels below.

Pharmedica USA, LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.

Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at +1 (623) 698 – 1752 or e-mail address at osm@pharmedicausa.com Monday to Friday between the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ).. 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.

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Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma as an over-the-counter product, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised.

Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product.

Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) is used as an eye lubricant and to relieve dryness of the eyes. The affected product is packaged in a white aluminum tube within a paper carton. The product can be identified by the photos provided below. The product was distributed nationwide in the United States, and by Delsam through internet retail sites. Delsam Pharma’s NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3.

Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately.

Consumers with questions regarding this recall can contact the distributor Delsam Pharma, LLC by phone at 1-866-826-1306 or by e-mail at delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST.

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Pfizer Inc. has announced that the U.S. Food and Drug Administration has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Priority Review is intended to direct attention and resources from regulatory authorities toward drugs that, if approved, could offer significant improvements over existing options for serious conditions in order to make these drugs available to patients faster. The FDA’s decision on the application is expected in 2023. The European Medicines Agency (EMA) has also accepted elranatamab’s marketing authorization application (MAA). The company is working closely with the EMA to facilitate their review and will provide updates on timing as appropriate.

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