FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris

The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris.

  • Bkemv is approved for the following treatment indications, which are also currently approved for
    Soliris:
    o the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce
    hemolysis; and
    o the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit
    complement-mediated thrombotic microangiopathy.
  • Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS).

Source: FDA

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YESAFILI AND OPUVIZ

The FDA has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye.

The FDA also approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept). Both Yesafili and Opuviz are the first interchangeable biosimilars to Eylea to treat certain eye conditions.
They are used to treat:

  • Neovascular (wet) age-related macular degeneration
  • Macular edema following retinal vein occlusion
  • Diabetic macular edema
  • Diabetic retinopathy
    Source: FDA

IMDELLTRA™

FDA Grants Accelerated Approval for Imdelltra for the Treatment of Extensive-Stage Small Cell Lung Cancer

The FDA has approved Imdelltra™ (tarlatamab-dlle), manufactured by Amgen, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

  • Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the
    patient’s own T cells to attack DLL3-expressing tumor cells.
  • Imdelltra is administered as an intravenous infusion over one hour in an appropriate hospital
    setting.

Source: Amgen

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GENERIC DRUG APPROVALS

May 2024

  • Edaravone Intravenous Solution 30mg/100mL and 60mg/100mL
    Approved: May 6, 2024 – Gland Pharma Limited; Hikma Pharmaceuticals USA Inc. (30mg/100mL
    only); Long Grove Pharmaceuticals, LLC (30mg/100mL only); Dr. Reddy’s Laboratories Limited
    (60mg/100mL only)
    Treatment for: Amyotrophic Lateral Sclerosis
    Generic for: Radicava
  • Emtricitabine and Tenofovir Alafenamide Fumarate Tablets 120mg/15mg (base) and 200mg/25mg
    (base)
    Approved: May 17, 2024 – Apotex Corp.
    Treatment for: HIV Infection
    Generic for: Descovy
  • Halcinonide Topical Solution 0.1%
    Approved: May 29, 2024 – Encube Ethicals Private Limited
    Treatment for: Inflammatory Skin Diseases
    Generic for: Halog Solution

Scientists May Have Located Your Brain’s ‘Neural Compass’

By Dennis Thompson, HealthDay Reporter; Medically reviewed by Drugs.com

Researchers say they’ve identified a human “neural compass” — a pattern of brain activity that helps prevent humans from becoming lost.

This discovery could increase understanding of diseases like Alzheimer’s and Parkinson’s, in which a person’s navigation and orientation are frequently impaired.

Future research will take these findings a step further, to figure out how the brain navigates through time and whether this brain activity is related to memory.

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Dr. Reddy’s Issues Recall of Sapropterin Dihydrochloride Powder

Dr. Reddy’s Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency.

  • Risk Statement: Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.

Source: FDA

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MYHIBBIN™

FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.

  • In 2023, there were over 46,000 transplants in the U.S. and these patients need to take medication every day to fight against rejection.
  • Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
  • It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.

Ream more…

AI Might Spot Rare Diseases in Patients Years Earlier

By Dennis Thompson, HealthDay Reporter; Medically reviewed by Carmen Pope, BPharm

Artificial intelligence (AI) might be able to identify patients who have rare diseases years earlier than they would typically be diagnosed, a new study says.

  • A newly developed AI program was able to successfully identify people at risk of developing a rare immune disorder, researchers report in Science Translational Medicine.
  • Out of a group of 100 people judged at highest risk by the AI program, 74 very likely have the disorder, researchers found. This shows that AI could potentially improve the outcomes of these folks by getting them earlier treatment.

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Otsuka Initiates Voluntary Nationwide Recall of Certain Lots of Abilify® Tablets Dueto Drug Product Cross-Contamination on Manufacturing Equipment

Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. FDA.

The Abilify® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. The recall will not affect product availability as there are other sources of aripiprazole tablets available in the U.S. market for patient use, including 2 mg and 20 mg.

Source: Otsuka America Pharmaceutical, Inc

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GENERIC DRUG APPROVALS

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