Roche is taking a quick look at the FDA approval of risdiplam for spinal cord injury


Roche expects risdiplam treatment for spinal muscular atrophy (SMA) in the United States by May, the Swiss-born drug said Monday, under Novartis and Biogen in the rare disease area.

The US Food and Drug Administration has given priority to the disease & # 39; Risdiplam & # 39 ;, an oral drug for those suffering from depression. Roche, whose medicine is seen as a competitor for biogen & # 39; s Spinraza and genetic treatments for & # 39; Novartis & # 39; of Zolgensma therapy, said the FDA should reach May 39th.

Roche is seeking broad approval for adults with a variety of SMAs, including a Type 1 killer that kills many infants in the first few months of life as well as Type 3 diabetes that may be present. later on but still releasing their victims physically. disable.

SMS has become a battle to fight drug makers, as well as the need for emergency treatment helped lead to some of the highest prices in the pharmaceutical industry.

Spinraza, which can be managed with a spinal cord, costs $ 750,000 for the first year and a half this year, while Novartis & # 39; s Zolgensma is the most expensive treatment in the industry for $ 2.1 million per patient.

Roche's findings "are intended to represent the real world view of people living with SMA and include many people who have previously been exposed to clinical trials," Roche Health Chief Levi Garraway said in a statement.

Spinraza has pledged $ 1.7 billion in revenue in 2018, but this year it has begun competing with Zolgensma following the approval of the genetic code in May. Zolgensma's sales have been $ 175 million since September.

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