BeneCard PBF compiles the latest pharmacy news from across the web, including new drug approvals, recalls, new generic drug approvals and more. The content is the property of the website owners, writers and contributors.
New Drug Approvals
KISUNLA™
FDA Approves Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease
July 2, 2024 – The U.S. Food and Drug Administration (FDA) has approved Kisunla™ (donanemab-azbt, 350mg/20mL injection for IV infusion) as treatment of early symptomatic Alzheimer’s disease (AD) which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.
- Once-monthly Kisunla IV infusion is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.
- Among the overall population of Phase 3 study participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.
- The FDA’s dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging.
Source: Eli Lilly and Company
TEPYLUTE
FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer
June 28, 2024 – Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved the company’s New Drug Application for Tepylute.
- Tepylute is a liquid form of a well-established, standard of care oncology drug, thiotepa. The new formulation eliminates the need for complex and time-consuming reconstitution, which can reduce the risk of drug preparation errors.
- Tepylute is a ready-to-dilute formulation to treat breast and ovarian cancer in an easier-to-prepare, injectable product that also enables dosing accuracy.
Source: FDA
OHTUVAYRE
FDA Approves Ohtuvayre for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)
June 26, 2024 – Verona Pharma plc announced that the U.S. Food and Drug Administration (FDA) has approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
- Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule.
- It is the first inhaled product in more than 20 years, with a novel mechanism of action available for the maintenance treatment of COPD and is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.
Source: Verona Pharma plc
PiaSky
FDA Approves PiaSky for the Treatment of Paroxysmal Nocturnal Hemoglobinuria
June 24, 2024 – The U.S. Food and Drug Administration (FDA) approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
- Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood condition in which red blood cells are destroyed by the body’s complement system (part of the innate immune system). This causes symptoms such as anemia, fatigue, and blood clots, and can lead to kidney disease.
- PiaSky contains crovalimab-akkz which is a C5 inhibitor that is recycled within the bloodstream, enabling sustained complement inhibition through low-dose administration every four weeks.
- PiaSky is administered as a single loading dose by intravenous infusion on Day 1, followed by four additional weekly loading doses administered by subcutaneous injection on Days 2, 8, 15, and 22. Maintenance dosing starts on Day 29 and is administered every 4 weeks by subcutaneous injection.
Source: FDA
SOFDRA™
FDA Approves Sofdra Topical Gel for the Treatment of Primary Axillary Hyperhidrosis
June 20, 2024 – Clinical dermatology company, Botanix Pharmaceuticals Ltd., announced the U.S. Food and Drug Administration (FDA) has approved Sofdra™ (sofpironium) gel, 12.45%, a prescription medicine used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and older.
- Hyperhidrosis is a condition characterized by abnormally increased sweating, beyond that required to regulate body temperature. The disproportionate sweat production that characterizes hyperhidrosis, results in a disabling medical condition with profound effects on the patient’s quality of life.
- Sofdra is the first and only new chemical entity approved by the FDA to treat primary axillary hyperhidrosis and presents a novel safe and effective solution for patients who have lacked treatment options for this socially challenging medical condition.
- Hyperhidrosis is the third largest dermatology condition (after acne and atopic dermatitis), with approximately 10 million patients in the US with primary axillary hyperhidrosis.
Source: Botanix Pharmaceuticals Ltd.
CAPVAXIVE™
FDA Approves Capvaxive™ for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults
June 17, 2024 – Merck has announced that the U.S. Food and Drug Administration (FDA) approved Captative™ (Pneumococcal 21-valent Conjugate Vaccine) for:
- Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
- Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases.
- The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvaxive in adults.
Source: Merck & Co., Inc.
VIGAFYDE™
FDA Approves Vigafyde™ as the First and Only Ready-to-Use Vigabatrin Oral Solution
June 17, 2024 – Pyros Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Vigafyde™, the only ready-to-use vigabatrin oral solution, as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss.
- Infantile spasms, a rare but severe form of epilepsy, pose significant challenges for patients and their families.
- Pyros provides ongoing personalized support to caregivers. The support program offers personal assistance and financial resources to caregivers whose child is starting or continuing therapy.
- Vigafyde™ is expected to be available in the second half of 2024.
Source: Pyros Pharmaceuticals, Inc.
YIMMUGO
FDA Approves Yimmugo to Treat Primary Immunodeficiencies
June 17, 2024 – Grifols announced that Biotest has received approval from the U.S. Food and Drug Administration (FDA) for Yimmugo, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).
- Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma to treat immunodeficiencies, in which a part of the body’s immune system is missing or does not function properly, and other medical conditions.
- The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes.
- As the first U.S.-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified “Next Level” production facility in Germany.
Source: Grifols
IQIRVO™
FDA Grants Accelerated Approval to Iqirvo for the Treatment of Primary Biliary Cholangitis
June 10, 2024 – Ipsen has announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Source: Ibsen Biopharmaceuticals, Inc.
Biosimilars
PYZCHIVA®
FDA Approves Pyzchiva, a Biosimilar to Stelara
July 1, 2024 – Sandoz has announced that the U.S. Food and Drug Administration (FDA) approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130mg/26mL (5mg/mL) single-dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the US.
- Pyzchiva® is approved by the FDA for all indications of the reference medicine Stelara®†(ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist including to treat adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis.
- In addition, the FDA provisionally determined that Pyzchiva® would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products.
- Sandoz intends to launch Pyzchiva® in the US in February 2025.
*Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd.
†Stelara® is a registered trademark of JOHNSON & JOHNSON (USA).
Source: Sandoz
AHZANTIVE®
FDA Approves Ahzantive, a Biosimilar to Eylea
June 28, 2024 – Formycon AG and Klinge Biopharma GmbH jointly announced that the U.S. Food and Drug Administration (FDA) approved FYB203/Ahzantive®.
Ahzantive is an injectable vascular endothelial growth factor (VEGF) inhibitor that is a biosimilar to Eylea (aflibercept), and is approved to treat the following eye conditions:
- Neovascular (Wet) age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR).
Source: Formycon AG
NYPOZI
FDA Approves Nypozi, a Biosimilar to Neupogen
June 28, 2024 – Tanvex BioPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved the biologics license application (BLA) of Nypozi.
- Nypozi, proposed biosimilar to the reference product Amgen’s NEUPOGEN® – is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
- Tanvex’s Nypozi has been launched in Canada in January 2024.
Source: Tanvex BioPharma, Inc.
Generic Drug Approvals
- Indium In-111 Pentetreotide Injection Kit3 mCi/mL
Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
Used for: Diagnosis and Investigation
Generic for: Octreoscan - Bupivacaine Liposome Injectable Suspension 133mg/10mL (13.3mg/mL) and 266mg/20mL (13.3mg/mL)
Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Used for: Analgesia
Generic for: Exparel - Palbociclib Tablets 75mg, 100mg and 125mg
Approved: June 5, 2024 – Synthon Pharmaceuticals, Inc.
Treatment for: Breast Cancer
Generic for: Ibrance Tablets - Avanafil Tablets 50mg, 100mg and 200mg
Approved: June 14, 2024 – Hetero Labs Limited
Treatment for: Erectile Dysfunction
Generic for: Stendra - Phentermine Hydrochloride and Topiramate Extended-Release Capsules 3.75mg (base)/23mg, 7.5mg (base)/46mg, 11.25mg (base)/69mg and 15mg (base)/92mg
Approved: June 25, 2024 – Actavis Laboratories FL, Inc.
Treatment for: Obesity
Generic for: Qsymia
Recalls
American Health Packaging on Behalf of BluePoint Laboratories Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
June 25, 2024 – American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.
Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsules.
Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or health care provider before they stop using the product. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Sedgwick, a recall solution vendor, at 1-855-695-8564, Monday – Friday, 8:00 am – 5:00 pm EST for return instructions and further information.
(Note: One Benecard Central Fill member was affected by this recall and member outreach was completed.)
Source: FDA
Glenmark Pharmaceuticals Inc., USA Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
June 24, 2024 – Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.
Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) capsules.
Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or health care provider before they stop using the product. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Inmar Rx Solutions at 1-877-883-9273, Monday – Friday, 9:00 am – 5:00 pm EST for return instructions and for further information.
(Note: Nine Benecard Central Fill members were affected by this recall and member outreach was completed.)
Source: FDA