All posts by : Admin

FDA Approval for Generic to Votrient

October 19, 2023 – Apotex Corp.; Sun Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA, Inc., have been approved by the FDA for the use of Pazopanib Hydrochloride Tablets (200 mg/base) for treatment of Renal Cell Carcinoma; Soft Tissue Sarcoma. This approval is as a generic to Votrient.

FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara

October 31, 2023 — The U.S. Food and Drug Administration has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
• Pediatric patients 6 years of age and older with:
• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
• active psoriatic arthritis.

The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.

Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever, and diarrhea.

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FDA Approves Bimzelx (bimekizumab-bkzx) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

October 18, 2023 – UCB, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

The FDA recommended dosage of bimekizumab for psoriasis patients is 320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12 and 16, then every 8 weeks thereafter. For patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered.

Bimekizumab may be administered by a healthcare professional, or a patient may self-inject after proper training. It is available as an autoinjector and a pre filled syringe and will be available in the U.S. in approximately one month.

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FDA Approves Xphozah (tenapanor) to Reduce Serum Phosphorus in Adults with Chronic Kidney Disease

Ardelyx, Inc., a biopharmaceutical company, has announced that the U.S. Food and

Drug Administration (FDA) has approved Xphozah (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Xphozah, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. Xphozah is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking Xphozah in clinical trials.

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FDA Approves Zilbrysq (zilucoplan) for the Treatment of Adults with Generalized Myasthenia Gravis

UCB, a global biopharmaceutical company, today announced that Zilbrysq® (zilucoplan) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.

Zilbrysq is the first once-daily subcutaneous, targeted peptide inhibitor of complement component 5 (C5 inhibitor). It is the only once-daily gMG target therapy for self-administration by adult patients with antiAChR antibody positive gMG.

gMG is a rare, chronic, heterogeneous, unpredictable autoimmune disease characterized by dysfunction and damage at the neuromuscular junction (NMJ).

Several factors are understood to be drivers of gMG disease pathology, including the complement cascade, immune cells, and pathogenic Immunoglobulin G (IgG) autoantibodies.

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