FDA Ultomiris Alexion allows for other rare blood diseases


(Reuters) – The Food and Drug Administration of the US. Friday treatment Alexion Pharmaceuticals Inc a second rare blood disorder, the company said.

The treatment, Ultomiris, has already been approved in the United States, Japan and the European Union to treat adults with blood disorders on them, called night-paroxysmal hemoglobinuria.

Friday approval allows use in dealing with hemolytic uremic uremic syndrome (aHUS), a condition that causes abnormal blood clots in small blood vessels in the kidneys, which may result in kidney failure.

The label for the treatment of cautions in boxes gives the most serious risks, the FDA most significant for life-threatening meingococcal infections or sepsis, which occurred in patients treated with Ultomiris.

The FDA approval is the shot of the druggist, who is pushing to expand the Ultomiris label as the US market exclusivity for his drugs, Soliris, which is selling the most, is threatened. The drug maker is pushing patients to convert to Ultomiris, which is considered to be a successor drug.

The analysts say that Ultomiris is also a more convenient option because it only needs to be inflated every eight weeks, compared to every fortnight for those on Soliris.

It is stronger than Soliris, said analyst Cowen, Phil Nadeau.

Patients administered Ultomiris will be given an initial dose of loading, and maintenance will be carried out every eight weeks thereafter depending on their body weight.

A price list of $ 6,404 per vial at Ultomiris, compared to $ 6,543 per vial for Soliris, equates to more than 80% of Alexion's total sales.

On average, the annual cost for Ultomiris maintenance doses is $ 458,000, causing a discount of about 33% on the labeled maintenance dose of Soliris in aHUS, causing Alexion.

Patients do not necessarily pay the drug price list. Out of pocket costs are dependent on the individual's health care plan and the length of treatment.

Ultomiris is expected to deliver sales of around $ 1.5 billion by 2024 for use in aHUS, Nadeau said.

Alexion is trying to keep his leadership in dealing with certain rare blood disorders and earlier this week she agreed to buy less Biotechnology Inc. for $ 930 million. This follows two acquisitions last year which added to rare drugs.

The company is also testing Ultomiris for use in patients with optical immune spectrum disorder autoimmune diseases and generalized myasthenia gravis.

Reporting by Manojna Maddipatla and Trisha Roy in Bengaluru; Additional reporting at Sanjana Shivdas in Bengaluru; Edited by Daniel Wallis

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