TECENTRIQ HYBREZA

FDA Approves Tecentriq Hybreza Anti-PD-(L)1 Cancer Immunotherapy

Genentech announced the U.S. Food and Drug Administration (FDA) approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs). The first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States.

  • Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).
  • It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin, and soft tissue cancer.
    Source: Genentech

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Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) forInjection 100mg/vial Due to the Presence of a Glass Particle

Gilead Sciences, Inc. announced it is issuing a voluntary recall of one lot of Veklury (remdesivir) for Injection 100mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation.

Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. The glass particulate can potentially travel, through the blood vessels, to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead has not received any reports of adverse events related to this recall.

Consumers and healthcare providers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 Monday to Friday 5am – 6pm PST or through their website at www.askgileadmedical.com. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: Gilead Sciences, Inc.

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BORUZU

FDA Approves Boruzu Ready-to-Use Injection for Multiple Myeloma and Mantle Cell Lymphoma

Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. Food and Drug Administration (FDA) approval of Boruzu, a new presentation of bortezomib for ready-to-use subcutaneous or intravenous (IV) administration. This new oncology product reduces the compounding preparation steps typically required with administration. This product references the branded product Velcade , a lyophilized powder requiring reconstitution before use.

  • Boruzu (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma.
  • Shilpa developed the molecule and Amneal will manufacture and commercialize the product. Boruzu is expected to launch with a unique J-code in the second quarter of 2025.
    Source: Amneal Pharmaceuticals, Inc.

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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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Skyclarys

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 Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

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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