Moneycontrol PRO

Roche launches Evrysdi, the only approved drug to treat Spinal Muscular Atrophy

Evrysdi, a breakthrough orally administered treatment for SMA patients, was first approved by the USFDA in August 2020 and is made available in India within 11 months of US approval.

July 29, 2021 / 08:14 PM IST

Swiss drug major Roche on July 29 launched Evrysdi (risdiplam), the first and only approved drug in India for Spinal Muscular Atrophy (SMA), a progressive rare neuromuscular disease.

Evrysdi, a breakthrough orally administered treatment for SMA patients, was first approved by the USFDA in August 2020 and is made available in India within 11 months of US approval. The treatment cost varies depending on weight and age, but a patient above 20 kg would have to pay a maximum of Rs 72 lakh for a full year treatment during the first two years with the patient support programme of Roche.

SMA is a severe, progressive rare neuromuscular disease that can be fatal. It affects approximately one in 10,000 live births globally and one in 7744 live births in India and is the leading genetic cause of infant mortality.

SMA is caused by a mutation of the survival motor neuron 1 (SMN1) gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly,

leading to muscle weakness over time. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.

Roche said since its launch, more than 4,000 SMA patients across 50 plus countries have benefitted from Evrysdi.

Close

COVID-19 Vaccine

Frequently Asked Questions

View more
How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

View more
Show

Pricing

One bottle of Evrysdi is priced at Rs 6 lakh in India. To further drive broader access to SMA patients in India, Roche announceed a patient support programme (PSP) for Evrysdi through which in the first two years of treatment, Roche will provide three bottles free for every two bottles bought by the patient. From the third year onwards, Roche will provide two bottles free for every one bottle bought by the patient.

Roche said it will provide free home delivery of Evrysdi to each and every patient.

The number of bottles or dosage is dependent on the weight and age of a person. For an infant weighing 5 Kg, one bottle will last for 60 days. This translates to about 6 bottles per year. A patient who is weighing more than 20 Kg requires about 31 bottles per year, which is the max use case. With PSP support, the patient would need to buy about 12 bottles per year in the first 2 years and about 10 bottles per year from the third year onwards.

“We are betting big on solving complex challenges related to rare diseases as we believe no patient should be deprived an opportunity to live a healthy life, however complex or rare the disease is," said V Simpson Emmanuel, CEO and Managing Director, Roche Pharma India.

"Today heralds a new journey of hope as we are all coming together to add colour into the lives of SMA patients in India with the launch of Evrysdi, the first and only approved treatment in India for patients living with SMA. This also marks our foray into rare disease treatment in India," he added.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jul 29, 2021 08:14 pm
Sections
ISO 27001 - BSI Assurance Mark