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Brazil Healthcare News, Pharma News | Drug approved in Brazil | iPharmaCenter

Ondexxya is prescribed for patients undergoing treatment with FXa inhibitors such as apixaban or rivaroxaban when there is an urgent need to reverse the anticoagulant effects due to severe or uncontrollable bleeding.

Ondexxya (andexanet alfa) is a genetically engineered FXa protein that has undergone modifications to render it inactive regarding physiological blood clotting factor activity. However, it still maintains a strong affinity for FXa inhibitors. Andexanet alfa effectively binds to FXa inhibitors like apixaban and rivaroxaban, exhibiting a binding affinity comparable to native FXa.

Clinical reports have shown that 80% of patients treated with andexanet alfa for life-threatening or uncontrollable major bleeding experienced excellent or good hemostasis. Additionally, the incidence of rebleeding was low, indicating that the administered doses are effective in reversing anticoagulation.

Horizon Therapeutics announced that in Brazil, Tepezza (teprotumumab) had received approval for treating active thyroid eye disease (TED). This marks the first and only medicine approved for active TED in Brazil, addressing a significant unmet need for individuals affected by this rare autoimmune disease that can lead to vision-threatening complications.

The approval of Tepezza by the Brazilian Health Regulatory Agency (ANVISA) in Brazil was based on the OPTIC Phase 3 clinical trial results. The trial demonstrated that 83% of patients treated with Tepezza experienced a meaningful improvement (≥2 mm) in proptosis, or eye bulging, at Week 24, compared to those who received a placebo. Tepezza was also found to alleviate symptoms such as diplopia (double vision), orbital pain, redness, and swelling while improving patients' functional vision and appearance.

Horizon Therapeutics is actively conducting three additional clinical trials for Tepezza in TED. These include a Phase 4 post-marketing study with sites in the United States and Europe and two Phase 3 trials in Japan. The first Japanese trial, known as OPTIC-J, focuses on evaluating the efficacy of Tepezza in TED patients with a disease duration of nine months or less and a high clinical activity score (CAS), which measures disease activity. The second trial aims to assess Tepezza's effectiveness in adults with two to ten years of disease and a low CAS.

TED is a rare autoimmune disease that is severe, progressive, debilitating, and has the potential to threaten vision. While TED often occurs in individuals with Graves' disease, it is a distinct condition caused by autoantibodies activating an IGF-1R-mediated signalling complex in cells within the retro-orbital space. Common signs and symptoms of TED include dry eyes, grittiness, redness, swelling, excessive tearing, eyelid retraction, proptosis, pressure or pain behind the eyes, and diplopia.


January 30, 2023

Mylan's insulin biosimilar, Semglee, is approved for type-2 diabetes mellitus.

Semglee was approved for treating adults and children with type 2 diabetes mellitus. The drug is developed to demonstrate efficacy versus the reference product, Lantus. Semglee is a long-acting insulin. There is an efficacy demonstration in terms of analytical, non-clinical, and clinical aspects versus Lantus.


January 30, 2023

Alexion's Ultomiris was approved for pediatric patients with paroxysmal nocturnal hemoglobinuria.

Ultomiris (ravulizumab) was approved for treating pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).

Alexion has received an extension of indication for pediatric patients; previously, it was approved for adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

The approval was based on Phase 3 ALXN210-PNH-304 trial, demonstrating the efficacy and safety of Ultromis in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).

The pharmacokinetic and pharmacodynamic studies further demonstrated that weight-based administration of Ultomiris showed inhibition of complete and sustained release of terminal complement, demonstrating an efficacy similar to adults.


January 23, 2022

Dupixent was approved for adults with Prurigo nodularis.

Sanofi's Dupixent (dupilumab) was approved for adults with Prurigo nodularis (PN). Dupixent is indicated with or without topical corticosteroids. It was approved for atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).

Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by skin itching for over six weeks. No approved treatments are available for Prurigo nodularis, and topical corticosteroids are used for managing symptoms. However, these therapies are ineffective in treating the disease.

The efficacy was demonstrated in two pivotal studies, demonstrating the efficacy in patients with moderate to severe prurigo nodularis. There was a significant improvement in all measures in PN patients. Dupixent 300 mg every two weeks reduced PN in patients and improved cardinal symptoms.


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