SMA patients welcome the development of generic drugs for NATCO; call for government intervention to ensure entry

The universal version of Risdiplam, a drug used to treat spinal muscle atrophy (SMA), was soon sold in India for $183.47 per bottle, a sharp drop of 97% from the current $7,150 price. The news is welcomed by healthcare activists and patients, which is a significant development.

Legal researcher KM Gopakumar said government intervention at this time is crucial.

“Even if this possible cost is reduced, the drug will remain expensive and for a large percentage of patients. The central government can intervene, procure these drugs and reduce prices in a more affordable way. They can also call the Section 100 Patent Act of 1970 to make a normal version of the drug and ensure that the drug is manufactured for all SMA patients.

Legal struggle

Indian general manufacturer NATCO Pharma announced that it can commercialize the Risdiplam of generic drugs for Rs 15,900, equivalent to $183.47. NATCO released this information in a legal battle with current drug patent holder Roche Pharma. The Delhi High Court has filed an interim injunction against NATCO for alleged infringement of its patents, dismissing Roche’s appeal.

Saifullah Khalidi, a SMA patient representative and disability rights advocate, said patients and their families are waiting for affordable treatment options.

“SMA is a lifelong condition, and Roche’s medication improves quality of life. Currently, for adult patients, the cost of drugs above Rs 7 lakh per year is as high as Rs 7 lakh per year. This makes the ongoing and continuous use of the drug an impossible task. So far, we have the possibility of when or when to start production or when it will provide patients with multiple companies. SMA patients,’’ he said.

Mr Khalidi added that without treatment, SMA patients have reduced mobility, respiratory challenges and shortened lifespan. “This drug is crucial to ensuring the quality of life for SMA patients,” he stressed.

Incurable

SMA is a genetic disease that causes weakness and waste or atrophy of muscles used for exercise. It is caused by the loss of motor neurons, specialized nerve cells in the spinal cord that controls muscle movement.

Symptoms depend on the type of SMA, but may include muscle weakness, dysfunction of movement, breathing problems, dysphagia, and scoliosis. There are currently no treatments for SMA, but treatment can help manage symptoms and improve quality of life through some therapies.

Evrysdi (Risdiplam) is a small molecule oral drug that is the first and only approved SMA treatment in India, made by Roche. In addition, another treatment for modifying the disease, Nusinersen (Spinraza), can be obtained in India through a special program for select children.

“Access to medicines means improved quality of life. I was able to raise Rs 6.1 lakh through crowdfunding in 2022, which allowed me to use Roche for nearly a year. However, I have never had this drug due to the easy-to-access generics.