KISUNLA™

FDA Approves Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease

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.

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VIGAFYDE™

FDA Approves Vigafyde™ as the First and Only Ready-to-Use Vigabatrin Oral Solution

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.

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PYZCHIVA®

FDA Approves Pyzchiva, a Biosimilar to Stelara

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).

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GENERIC DRUG APPROVALS

July 2024

  • Indium In-111 Pentetreotide Injection Kit 3mCi/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
  • L-Glutamine Powder for Oral Solution 5gm/packet
    Approved: July 8, 2024 – Novitium Pharma LLC
    Used for: Sickle Cell Disease
    Generic for: Endari
  • Nimodipine Oral Solution 3mg/mL
    Approved: July 9, 2024 – Annora Pharma Private Limited
    Used for: Subarachnoid Hemorrhage
    Generic for: Nymalize
  • Tazarotene Topical Cream 0.05%
    Approved: July 15, 2024 – Padagis Israel Pharmaceuticals Ltd.
    Used for: Plaque Psoriasis
    Generic for: Tazorac Cream 0.05%