Is Zolgensma available in Canada?

Newborn screening pilot to begin in Alberta Coverage for Zolgensma, a gene therapy used to treat spinal muscular atrophy, is now permanently available in Alberta.

Is gene therapy available in Canada?

On October 14, 2020, Health Canada announced their approval of the first targeted gene-therapy treatment voretigene neparvovec (Brand name: Luxturna) for an inherited retinal disease (IRD). This announcement is the first targeted gene therapy approved in Canada for any disease.

When was Zolgensma approved in Canada?

16, 2020 /CNW/ – Novartis Pharmaceuticals Canada Inc. is pleased to announce that Health Canada has approved Zolgensma® (onasemnogene abeparvovec) an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients with 5q spinal muscular atrophy (SMA) with bi-allelic mutations …

Is Zolgensma free in Canada?

Before Health Canada approved Zolgensma in mid-December, maker Novartis had offered a lottery program for Canadians to get free doses. After Zolgensma was approved in Canada, however, the pharmaceutical company withdrew the managed access program, leaving Canadian families with few alternatives.

How much is Zolgensma in Canada?

Health Canada has approved Zolgensma, which is bringing renewed hope to Alberta families that have been tirelessly fundraising to afford its staggering cost of $2.8 million. At least four children in Alberta have been diagnosed with the rare and debilitating disease spinal muscular atrophy (SMA).

Is Spinraza available in Canada?

SPINRAZA™ (nusinersen) is approved by Health Canada, and Biogen and pCPA have reached an agreement to ensure SMA patients in Canada have access to treatment.

Is somatic gene therapy legal in Canada?

Gene therapies are being approved for use in Canada, but could strain healthcare budgets and exacerbate existing treatment inequities across the country.

How is gene therapy regulated in Canada?

In Canada, gene therapies and oncolytic viruses for use as therapeutic agents to treat cancer are regulated as drugs under the Food and Drugs Act (R.S.C., 1985, c.F-27) (Food and Drugs Act) and associated regulations, including the Food and Drug Regulations (C.R.C., c. 870).

Who created Zolgensma?

Zolgensma was developed by AveXis, a Chicago-headquartered biotech that Novartis bought in 2018 for $8.7bn. AveXis’ intellectual property holdings and licensing agreements are key according to Althoff, who cites the firm’s deal with Rockville, Maryland-based Regenxbio as an example.

Does OHIP cover Zolgensma?

Spinraza, a gene-modifying treatment, was approved in Canada in 2017 and is covered in Ontario. But Zolgensma is not covered by any provincial health plans.

Is Zolgensma covered by OHIP?

What is Zolgensma gene therapy and how does it work?

Health Canada has approved Novartis ‘ gene therapy Zolgensma (onasemnogene abeparvovec) to treat pediatric spinal muscular atrophy (SMA) patients who have three or fewer copies of the SMN2 gene, or with infantile-onset disease.

How much does it cost to treat Zolgensma?

The single, one-time gene therapy called Zolgensma costs $2.8 million and is reportedly the only possible cure on the market. It has not been approved by Health Canada. For the drug to be effective, Eva has to receive it before she turns 2 years old.

Where can I get Zolgensma in Canada?

Thirteen sites in Canada have been cleared to administer Zolgensma: Vancouver, Edmonton, Calgary, Saskatoon, Winnipeg, London, Hamilton, Toronto, Ottawa, Montreal, Quebec City and Halifax. Before Health Canada’s approval, patients could only access Zolgensma through a federal special access program at a roughly $2.8-million cost.

How is Zolgensma approved to treat SMA in children?

The efficacy and safety data supporting the approval of Zolgensma in treating pediatric patients with SMA are derived from completed and ongoing open-label, single-arm, clinical trials in patients with infantile-onset SMA and 2 copies of SMN2 gene; and presymptomatic genetically diagnosed SMA and 2 or 3 copies of SMN2 gene 1.