Posts in category: News

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).

Read more…

FDA Approves Nypozi, a Biosimilar to Neupogen

– Tanvex BioPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved the biologics license application (BLA) of Nypozi.

• Nypozi, proposed biosimilar to the reference product Amgen’s NEUPOGEN® – is indicated to
  decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant
  incidence of severe neutropenia with fever.
• Tanvex’s Nypozi has been launched in Canada in January 2024.

Read more…

American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21
batches of Potassium Chloride Extended-Release Capsules, USP (750mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsules

Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult
with their physician or health care provider before they stop using the product. Consumers should also
contact their physician or healthcare provider if they have experienced any problems that may be related
to taking or using this drug product. Consumers should call Sedgwick, a recall solution vendor, at 1-855-
695-8564, Monday – Friday, 8:00 am – 5:00 pm EST for return instructions and further information. (Note: One Benecard Central Fill member was affected by this recall and member outreach was completed.)\

Read more…

FDA Approves PiaSky for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

The U.S. Food and Drug Administration (FDA) approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.

• Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood condition in which
  red blood cells are destroyed by the body’s complement system (part of the innate immune
  system). This causes symptoms such as anemia, fatigue, and blood clots, and can lead to kidney
  disease.
• PiaSky contains crovalimab-akkz which is a C5 inhibitor that is recycled within the bloodstream,
  enabling sustained complement inhibition through low-dose administration every four weeks.
• PiaSky is administered as a single loading dose by intravenous infusion on Day 1, followed by four
  additional weekly loading doses administered by subcutaneous injection on Days 2, 8, 15, and 22.
  Maintenance dosing starts on Day 29 and is administered every 4 weeks by subcutaneous injection.

Read more…

Clinical dermatology company, Botanix Pharmaceuticals Ltd. announced the U.S. Food and Drug Administration (FDA) has approved Sofdra™ (sofpironium) gel, 12.45%, a prescription medicine used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and
older.

• Hyperhidrosis is a condition characterized by abnormally increased sweating, beyond that required
  to regulate body temperature. The disproportionate sweat production that characterizes
  hyperhidrosis, results in a disabling medical condition with profound effects on the patient’s quality
  of life.
• Sofdra is the first and only new chemical entity approved by the FDA to treat primary axillary
  hyperhidrosis and presents a novel safe and effective solution for patients who have lacked
  treatment options for this socially challenging medical condition.
• Hyperhidrosis is the third largest dermatology condition (after acne and atopic dermatitis), with
  approximately 10 million patients in the US with primary axillary hyperhidrosis.

Read more…

FDA Approves Yimmugo to Treat Primary Immunodeficiencies

Grifols announced that Biotest has received approval from the U.S. Food and Drug Administration (FDA) for Yimmugo, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).

• Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood
  plasma to treat immunodeficiencies, in which a part of the body’s immune system is missing or
  does not function properly, and other medical conditions.
• The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary
• antibody deficiency syndromes.
• As the first U.S.-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified “Next Level” production facility in Germany.

Read more…

FDA Approves Capvaxive™ for Prevention of Invasive Pneumococcal Disease and
Pneumococcal Pneumonia in Adults

Merck has announced that the U.S. Food and Drug Administration (FDA) approved Captative™ (Pneumococcal 21-valent Conjugate Vaccine) for:

• Active immunization for the prevention of invasive disease caused by Streptococcus
  pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
• Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases.
• The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvaxive in adults.

Read more…

FDA Grants Accelerated Approval to Iqirvo for the Treatment of Primary Biliary Cholangitis

Ipsen has announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Read more…