MIPLYFFA™

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FDA Approves Miplyffa for the Treatment of Niemann-Pick Disease Type C

Zevra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Miplyffa™ (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC).

  • The first NPC drug approved by the FDA, Miplyffa is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.
  • Those living with NPC experience progressive physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills.
    Source: Zevra Therapeutics, Inc.

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Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone OralSuspension Due to Bacterial Contamination

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Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.

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 inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.

Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email to drugsafety@bionpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product.

Source: FDA
Note: No BCF members were affected by this recall.

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OCREVUS ZUNOVO

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FDA Approves Ocrevus Zunovo. A Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

Genentech, announced the U.S. Food and Drug Administration (FDA) approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

  • Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP) administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.
  • Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, with a decade of treatment for multiple sclerosis.
    Source: Genentech

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EBGLYSS

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FDA Approves Ebglyss for the Treatment of Atopic Dermatitis

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

  • Eczema inflammation under the skin can lead to symptoms seen and felt on the outside. Ebglyss works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin.
    Source: Eli Lilly and Company

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TECENTRIQ HYBREZA

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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

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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

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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™

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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

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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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