Dear Members of the European Medical Agency (EMA), 

Dear Members of the Committee for Medicinal Products for Human Use (CHMP), 

Dear President of the European Commission Ursula von der Leyen, 

Dear Supporters and concerned family members of the affected,

the Wold Duchenne Awareness Day just passed (Sept. 7th) and it was supposed to bring the world together and raise hopes for all people living with this devastating and deadly disease.

Sadly, for months now these hopes have been clouded again by the negative recommendation of the EMA to withdraw the Translarna medication from the market, the only medicine capable of saving these lives of patients with genetical mutation causing the disease.

About one year ago, when EMA issued its first negative opinion, the desperate battle of patients, families, organizations and medical specialists in in their conviction based on proven outcome, convinces the European Commission to reject the negative recommendation and asked EMA to consider:

- the opinion of a Specialized Advisory Group of medical specialists in the   domain
- the real-world proven positive outcome of treated patients
- the overwhelming positive date available in registers of treated patients
- the positive opinion of medical specialists treating directly these patients for many years

Therefore the European Commission asked the EMA to reconsider keeping the medication on the market in order to save lives. Translarna is the only chance for 800+ patients in Europe (including my son Andreas Wirsz) have in order to be able to continue their lives. 

Therefore the European Commission’s decision not to endorse the negative recommendation by EMA was an unimaginable relief to all of us, to the entire Duchenne Community - our dreams and hopes came through!

However the EMA hasn’t taken into account or hasn’t implemented the above listed requests by the European Commission. The EMA reissued its original negative recommendation in record time. This is an unimaginable injustice and deeply disappointing! 

As such the Death Sentence for these patients has been again expressed by the EMA.

The EMA argues with a so called „cost/benefit ratio“. 

Life is not a cost! Life is a gift for everyone and the patients have the same human right as anybody else to be treated with a medication that truly helps them to survive.

My Son Andreas Wirsz is 32 years old and is taking Translarna as his medication for 17 years which is the only reason he is still alive!

He bypassed by far the life expectancy given to him when he was 2 years old (being told he barely will ever get to live beyond 18).

Why take away from him and all the other patients their human right to live?

Hundreds of patients rely on Translarna being available to them which many take already for 10+ years and are able to stay alive. Patients, that use this medication in an early age, even live normal lives with virtually no symptoms or with a heavily slowed-down progression of the disease.

There aren’t any arguments against continuing the treatment with Translarna which would equal as a death sentence for 800+ patients in Europe.

WE DEMAND JUSTICE FOR ALL PATIENTS AND URGE THE EUROPEAN COMMISSION TO LET TRANSLARNA STAY AVAILABLE ON THE MARKET!

PLEASE HELP US FIGHT AGAINGST THIS UNFOUNDED AND DEADLY RECOMMENDATION BY THE EMA!

PLEASE SIGN THIS PETITION, SHARE THE INFORMATIONS AND HELP US SAVE THE LIVES OF OUR BELOVED FAMILY MEMBERS AND FRIENDS!

 

 

LUCIA WIRSZ, 

MOTHER TO TRANSLARNA PATIENT ANDREAS WIRSZ