LUMISIGHT™

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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SELARSDI

FDA Approves Selarsdi, a Biosimilar to Stelara

The FDA has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.

  • Introduced through a strategic partnership between Teva Pharmaceutical Industries Ltd. and Alvotech, for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, Teva will be responsible for the exclusive commercialization of Selarsdi in the United States.
  • Sales of Stelara in the U.S. were nearly $7 billion in 2023. The availability of a Stelara biosimilar will create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients.
  • In the U.S., plaque psoriasis is the most common form of psoriasis while psoriatic arthritis accounts for approximately six percent of all cases of juvenile arthritis.

Source: Teva Pharmaceutical Industries Ltd.

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ANKTIVA

FDA Approves Anktiva Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

ImmunityBio, Inc. has announced that the FDA has approved Anktiva plus Bacillus CalmetteGuérin (BCG) for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

  • Anktiva is a first-in-class IL-15 agonist immunotherapy for NMIBC and received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR).
  • Bladder cancer is the 10th most commonly diagnosed cancer globally, and in the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024.
  • With the approval of Anktiva in combination with BCG, NMIBC, patients who would otherwise face highly invasive surgery with life long consequences have an important new therapeutic option with a long-term durable complete response.

Source: ImmunityBio, Inc.

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ZEVTERA®

FDA Approves Zevtera for Bacteremia, Skin and Skin Structure Infections, and Pneumonia

The FDA has approved Zevtera® injection (ceftobiprole medocaril sodium) for the treatment of adult patients with Staphylococcus aureus bloodstream infections, including those with:

o Right-sided infective endocarditis
o Adult patients with acute bacterial skin and skin structure infections (ABSSSI)
o Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

  • Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria.
  • Zevtera is contraindicated in patients with a known history of severe hypersensitivity to Zevtera, or to other members of the cephalosporin class.

Source: Basilea Pharmaceutica Ltd

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XROMI

FDA Approves Xromi Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia

Xromi has been approved by the FDA as an oral solution formulation of hydroxyurea indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.

  • Sickle cell anemia is caused by an abnormal version of hemoglobin called hemoglobin S, which leads to sickle-shaped red blood cells that can form painful clumps inside the blood vessels. These painful episodes are called sickle cell crises and are one of the most common and distressing symptoms of sickle cell disease.
  • Hydroxyurea has been shown to reduce the frequency of painful episodes associated with sickle cell disease. It is thought to work by increasing levels of hemoglobin F (also called fetal hemoglobin because it is present in newborn babies) to make the red blood cells bigger, rounder, more flexible, and less likely to turn into a sickle shape.
  • Xromi, manufactured by Nova Laboratories, Ltd., is supplied as a strawberry flavored oral solution containing 100 mg/mL hydroxyurea. The Xromi package contains two oral dosing syringes.

Source: FDA

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RISVAN®

FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia

Laboratorios Farmacéuticos ROVI, S.A. has announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.

Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.

Schizophrenia is a chronic, serious, and disabling mental disorder that affects around 1% of the world population. Schizophrenia patients are characterized by a mixture of symptoms, both positive (delusional ideas, hallucinations, disorganized language, and behavior) and negative (affective flattening, speech poverty, apathy) in nature. It is estimated that between 3% and 5% of total global healthcare expenditure is spent on schizophrenia.

Read more at Drugs.com…