FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris

by News

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

by NewsUncategorized

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™

by NewsUncategorized

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

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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

MYHIBBIN™

by NewsUncategorized

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.

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ZITUVIO

by BusinessNews

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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Daybue™

by NewsUncategorized

FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

Acadia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first and only drug approved for the treatment of Rett syndrome.

Rett syndrome is a complex, rare, neurodevelopmental disorder typically caused by a genetic mutation on the MECP2 gene. It is characterized by a period of normal development until six to 18 months of age, followed by significant developmental regression with loss of acquired communication skills and purposeful hand use. Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. Rett syndrome is believed to affect 6,000 to 9,000 patients in the U.S.,with a diagnosed population of approximately 4,500 U.S. patients. Daybue is not recommended for patients with moderate or severe renal impairment.

Daybue™ is expected to be available in the U.S. by the end of April, 2023.

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