I am 21 years old and living with Friedreich’s Ataxia, a progressive neurodegenerative disease that has slowly taken away my mobility and independence. Skyclarys (Omaveloxolone) isn't just another medication for us – it's our hope, our chance for more time, a shot at maintaining our independence, and keeping our dreams alive.

For the past four years, we have pleaded with our government to make this life-changing drug available in Iran. Unfortunately, our requests have been dismissed repeatedly, with the excuse that Skyclarys is "too expensive." But what is the true cost of denying patients like me the right to a better quality of life?

Around the world, Skyclarys has shown promising results, significantly slowing the progression of Friedreich’s Ataxia and enhancing patients’ ability to maintain their daily activities. It has been approved in various countries and presents a tangible solution to a relentless condition that affects thousands globally. There are no alternative treatments that offer such potential.

We ask the Iranian government, healthcare providers, and phar

maceutical companies to urgently prioritize negotiations and arrangements to make Skyclarys available for the treatment of Friedreich’s Ataxia in Iran. We need action and compassion, not excuses and delays. This medication could change lives, giving us the time to live our lives to the fullest, hold onto our independence, and pursue our dreams. The families and individuals impacted by this debilitating disease deserve nothing less.

Please sign this petition to show your support and help us send a powerful message to those in power. Together, we can make a difference and ensure that no one else loses their dreams to Friedreich’s Ataxia.

 

 

 

 

 

The official IFDA rejection letter 
Date: 1404/01/20
From: Mehdi Pirsalehi, Deputy Minister and Head of Iran Food & Drug Administration

Subject: Official Response Regarding Omaveloxolone (Skyclarys) Access in Iran

Content:

The Iranian Food & Drug Administration (IFDA) has provided the following explanation regarding the importation of Omaveloxolone (Skyclarys):
 1. Omaveloxolone has not yet been added to Iran’s national drug list because:
 • It was only approved by the FDA in 2023,
 • IFDA claims that there is “insufficient international safety and efficacy data.”
 2. The drug’s high cost (approximately 200,000–300,000 USD per patient per year) makes direct import “not feasible under current economic conditions.”
 3. IFDA suggests that domestic companies or the Vice Presidency for Science and Technology explore the possibility of producing a similar drug locally.
 4. IFDA emphasizes that financial support could be available for domestic production, but direct import is “currently not feasible.”

Interpretation / Context:
While the official reasons mention safety data and cost, FDA approval and peer-reviewed studies from 2023 are fully public. This indicates that the main barriers are financial and administrative, not related to drug safety.

Without international attention or advocacy, there is little likelihood of progress for Iranian FA patients to access this life-saving medicine