Posts in category: Uncategorized

APRIL 2024

• Valbenazine Tosylate Capsules 40 mg (base) and 80 mg (base)
  Approved: April 5, 2024 – Lupin Pharmaceuticals, Inc.
  Treatment for: Huntington’s Disease, Tardive Dyskinesia
  Generic for: Ingrezza
• Eribulin Mesylate Intravenous Solution 1 mg/2 mL (0.5 mg/mL)
  Approved: April 5, 2024 – Gland Pharma Limited
  Treatment for: Breast Cancer, Liposarcoma
  Generic for: Halaven
• Doxycycline (Anhydrous) Immediate/Delayed Release Capsules 40 mg
  Approved: April 8, 2024 – Dr. Reddys Laboratories Inc.; Lupin Pharmaceuticals, Inc.
  Treatment for: Rosacea
  Generic for: Oracea
• Estradiol Transdermal Gel (Metered) 0.06% (1.25 g/activation)
  Approved: April 22, 2024 – Solaris Pharma Corporation
  Treatment for: Menopausal Symptoms
  Generic for: EstroGel
• Deflazacort Oral Suspension 22.75 mg/mL
  Approved: April 25, 2024 – Tris Pharma Inc.
  Treatment for: Duchenne Muscular Dystrophy
  Generic for: Emflaza Suspension
• Midostaurin Capsules 25 mg
  Approved: April 29, 2024 – Teva Pharmaceuticals USA, Inc.
  Treatment for: Acute Myeloid Leukemia, Systemic Mastocytosis
  Generic for: Rydapt

FDA Approves Ingrezza® Sprinkle (valbenazine) Capsules for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.

Neurocrine Biosciences, Inc. has announced the FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral granules formulation of Ingrezza (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.

• Ingrezza Sprinkle provides an alternative administration option for those who experience dysphagia or
• have difficulty swallowing.
• Ingrezza (valbenazine) offers simple dosing that’s always one capsule, once daily with no complex titration. It is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers three effective dosages (40 mg, 60 mg and 80 mg) that can be adjusted by the healthcare provider based on patient response and tolerability.

Source: Neurocrine Biosciences, Inc.

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FDA Approves Hercessi, a Biosimilar to Herceptin

Accord BioPharma, Inc., announced that the FDA has approved Hercessi™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

• Hercessi and its reference product, Herceptin (trastuzumab), are highly similar in terms of efficacy, safety, and quality. Hercessi works by binding to and inactivating the HER2 receptor, slowing down cell replication.

• The safety profile of Hercessi has been shown to be consistent with the safety profile for the reference
  product Herceptin. The data demonstrates that there are no clinically meaningful differences between Hercessi and Herceptin in the populations studied and support biosimilarity between the two therapies.
• Hercessi was approved by the FDA at a dosage of 150mg. A 420mg-strength version of Hercessi is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024.

Source: Accord BioPharma

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FDA Approves Libervant™ Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

Aquestive Therapeutics, Inc. has announced that the FDA has approved Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between 2 to 5 years of age.

• In 2023, over 55,000 prescriptions were filled for patients between the ages of 2 and 5. This was an increase of 10.8% over the previous year. Prescription writing for this indication is highly concentrated among pediatric epileptologists and pediatric neurologists.
• Libervant™ is a film formulation of diazepam administered inside the cheek. Do not give Libervant™ to your child if your child is allergic to diazepam or any of the ingredients in Libervant™ or has an eye problem called acute narrow angle glaucoma.

Source: Aquestive Therapeutics, Inc.

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FDA Approves Xolremdi (mavorixafor) for Use in Patients with WHIM Syndrome

The FDA has approved Xolremdi™ capsules, manufactured by X4 Pharmaceuticals, for use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.

• WHIM syndrome is a rare, combined primary immunodeficiency and chronic neutropenic disorder caused by CXCR4 receptor dysfunction that results in impaired mobilization of white blood cells from the bone marrow into peripheral circulation. It is estimated that at least 1,000 people are currently diagnosed with WHIM syndrome in the U.S.

Source: X4 Pharmaceuticals

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FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B

Beqvez™, manufactured by Pfizer for the treatment of adults with moderate to severe hemophilia B, has been approved by the FDA for patients with the following:

o Currently use factor IX (FIX) prophylaxis therapy, or
o Have current or historical life-threatening hemorrhage, or
o Have repeated, serious spontaneous bleeding episodes, and
o Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.

• Beqvez is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month.
• Hemophilia B is a rare genetic bleeding disorder that prevents normal blood clotting because of a deficiency in FIX that causes those with the disease to bleed more frequently and longer than others.
• According to the World Federation of Hemophilia, more than 38,000 people worldwide are living with hemophilia B.

Source: Pfizer Inc.

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FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections

The FDA approved Pivya tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

• Pivya’s efficacy in treating females 18 years of age or older with uncomplicated UTIs was assessed in three controlled clinical trials comparing different Pivya dosing regimens to placebo, ibuprofen and another oral antibacterial drug.
• Patients should not use Pivya if they have a known history of severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs.
• The FDA granted the approval of Pivya to UTILITY Therapeutics Ltd.

Source: UTILITY Therapeutics Ltd.

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FDA Grants Accelerated Approval for Ojemda for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma

The FDA has provided accelerated approval to Day One Biopharmaceuticals, Inc. for Ojemda (tovorafenib), a type II RAF inhibitor.

• pLGG is the most common brain tumor diagnosed in children, with patients suffering profound tumorand treatment-associated morbidities that can impact their life trajectory. With this approval, Day One Biopharmaceuticals has received a rare pediatric disease priority review voucher from the FDA. Until now, there had been no medicines approved for patients with pLGG driven by BRAF fusions. Ojemda is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
• BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration. Ojemda is the only systemic therapy for pLGG that offers once-weekly dosing, with or without food, as a tablet or oral suspension.

Source: Day One Biopharmaceuticals, Inc.

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FDA Approves Rezenopy Nasal Spray for the Emergency Treatment of Opioid Overdose

The FDA has approved Rezenopy (naloxone hydrochloride) nasal spray 10mg for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. Rezenopy is manufactured by Summit Biosciences Inc.

• Rezenopy is a high dose naloxone hydrochloride nasal spray formulation containing 10mg of naloxone per spray available on prescription. Rezenopy nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
• Naloxone hydrochloride is an opioid antagonist that works to reverse the effects of opioids during an overdose, including respiratory depression, sedation, and hypotension.
• Common adverse reactions reported with Rezenopy include upper abdominal pain, nasopharyngitis and dysgeusia.

Source: FDA

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FDA Approves Lumisight™ Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy

The FDA approved Lumicell, Inc.’s New Drug Application (NDA) for its Lumisight™ (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™.

• Lumicell, Inc., is a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery.
• With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity postlumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries.
• The safety of the system was established using data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers across the U.S.

Source: Lumicell, Inc.

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