Regulatory Index News: 02/08/2018

Welcome to your Regulatory Index News update today, including two European approvals for Aegerion Pharmaceuticals' Myalepta and Pfizer's biosimilar Trazimera plus a FDA Phase 3 go-ahead.

Myalepta becomes the first and only licensed medication to treat the ultra-rare condition lipodystrophy

Aegerion Pharmaceuticals' Myalepta has been approved by the European Commission as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy patients. Lipodystrophy is an ultra-rare and incurable disease which impacts a person’s ability to store fat in their body, and can either be generalised (GL) or partial (PL). Myalepta becomes the first and only licensed medication in the treatment of lipodystrophy, something that affects approximately 1 to 4 people per million  Please click here to read more on this from a PharmaTimes article. 


The European Commission has approved Pfizer's Herceptin (trastuzumab) biosimilar Trazimera

Trazimera, Pfizer's Herceptin (trastuzumab) biosimilar and their first oncology biosimilar has received approval from the European Commission. It is licensed to treat human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The approval is based on data that includes results from the REFLECTIONS B327-02 clinical comparative study, showing clinical equivalence and finding no clinically meaningful differences between Pfizer's product and the originator product in patients with first line HER2 overexpressing metastatic breast cancer. Please click here to read more on this from a PharmaTimes article.




Phase III go ahead from FDA propels Arca Biopharma's Gencaro forward

Folllowing FDA's feedback in an end-of-Phase II meeting, Arca Biopharma plans to submit a special protocol assessment for its planned Phase III study for its beta-blocker and vasodilator Gencaro (bucindolol). The drug, which was originally developed for hypertension and heart failure but was sidelined after failing to reduce the risk of death by any cause in a 2,708-patient National Institutes of Health-sponsored study, now has FDA Fast Track Designation as a potential genetically targeted cardiovascular therapy.  Please click here to read more on this from a BioPharmaDive article.



Lorna Osborn

Date Published

02nd August 2018

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