Posts in category: Business

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 Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra® (tocilizumab). Tyenne becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the U.S. commencing on the license dates, which are confidential.

Tyenne has launched globally in more than 10 countries, with plans to launch in many more countries between 2024 and 2025. Tyenne (tocilizumab-aazg) is FDA approved for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

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FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva

Sandoz, announced that the U.S. Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva. Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

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FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines

Hugel America, Inc., a division of Hugel Inc., today announced it received U.S. Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults. In the coming months, Hugel plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the back half of 2024.

FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe. This botulinum toxin type A has been the leading neurotoxin brand in South Korea, one of the world’s most dynamic aesthetic markets, for seven consecutive years. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canada, and Europe.

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FDA Approves Exblifep for the Treatment of Complicated Urinary Tract Infections

Allecra Therapeutics (“Allecra”) announced that the U.S. Food and Drug Administration has approved Exblifep as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The GAIN Act, enacted by the U.S. Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs).

Exblifep is a combination antibiotic used for complicated urinary tract infections (cUTIs) that contains two antibiotics, cefepime and enmetazobactam. Exblifep is used when the bacteria causing the UTI is resistant to other antibiotics, especially if the resistance is due to Extended Spectrum Beta Lactamases (ESBLs).

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FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite
The U.S. Food and Drug Administration (FDA) approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The FDA granted the approval of Aurlumyn to Eicos Sciences Inc.

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

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Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.

Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.

8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01, Figure 2). The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

Product was distributed nationwide to wholesalers, distributors, and health systems between January 18,
2022, and February 15, 2023.