Posts in category: Business

FDA Approves Vyloy for the Treatment of Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

• Gastric and gastroesophageal junction (G/GEJ) cancer is the fifth most commonly diagnosed cancer worldwide.
• Vyloy is the first and only CLDN18.2-targeted therapy approved in the U.S.

Source: Astellas Pharma US, Inc.

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FDA Approves Nemluvio for the Treatment of Adult Patients with Prurigo
Nodularis

Galderma announced the U.S. Food and Drug Administration (FDA) approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.

• Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
• Prurigo nodularis is an underdiagnosed neuroimmune skin disease which is estimated to affect up to 181,000 people in the United States, and is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.
• Nemluvio specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.

Source: Galderma

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FDA Approves neffy® (epinephrine nasal spray) Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

ARS Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30kg (66lbs).

• The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.
• Type I allergic reactions, including those caused by food, medications, and insect bites, can lead to lifethreatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER.

Source: ARS Pharmaceuticals, Inc.

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FDA Approves Crexont Extended-Release Capsules for the Treatment of Parkinson’s Disease

Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD).

• Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediaterelease (IR) granules and extended-release (ER) pellets. Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses.
• There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes.

Source: Amneal Pharmaceuticals, Inc.

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FDA Approves Voranigo for the Treatment of Grade 2 IDH-Mutant Glioma

Servier today announced the U.S. Food and Drug Administration (FDA) approved Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor

• It is indicated for the treatment of:
  o adult and pediatric patients 12 years and older,
  o with Grade 2 astrocytoma or oligodendroglioma,
  o with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

• Voranigo is available and offers glioma patients the ability to actively manage their disease with the convenience of a once-daily pill. Gliomas are types of brain cancer that can hinder normal brain function and cause a variety of symptoms. Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumors diagnosed in adults younger than 50 years of age.

Source: Servier

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FDA Approves Zituvio (sitagliptin) for the Treatment of Adult Patients with Type 2 Diabetes Mellitus
Zydus Lifesciences has announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvio (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. Zituvio contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Zituvio is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Zituvio is not recommended in patients with type 1 diabetes mellitus. Zituvio has not been studied in patients with a history of pancreatitis.

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