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In recent months, there have been significant developments in the context of aHUS in India such as the approval of Soliris in India and clinical trials for Crovalimab and Iptacopan. This marks an exciting period for aHUS patients, families, and doctors in India. For many years, there was little positive news regarding this disease in our country, but thankfully, that is changing.

The aHUS India Foundation is launching a newsletter to provide important updates on aHUS developments relevant to India. Given the recent advancements in aHUS treatment and research in India, we believe it is an opportune time to start this initiative. Our newsletter will be sent out approximately every 2-3 months, keeping you informed about the latest news and progress in this field.

If you would like to stay updated on these advancements, please sign up for our newsletter. Rest assured, your email and any other details you provide will remain confidential. It is crucial for us to unite, pool our resources, and advocate for ourselves because no one else will do it for us. Sign up here, and we will keep you informed. Thank you.

Soliris recommended for approval for aHUS in India

In some very welcome news for Indian aHUS patients who are not generally used to any such news, the Experts Committee under India's drug regulator, the Central Drug Standard Control Organisation (CDSCO) has recommended to grant approval to Astra Zeneca (the company that owns Alexion Pharmaceuticals) to import and market the drug Soliris (Eculizumab) in India.

Some important takeaways:

1. This approval is subject to Astra Zeneca India conducting Phase IV clinical trials to establish safety and effectiveness in the Indian population. There is no clarity yet on how this will be done and how long it will take.

2. Only "Centres of Excellence" will be authorised to prescribe this drug. This is likely to include reputed institutes such as AIIMS, PGI, Chandigarh etc.

3. There is still no clarity on when the drug will actually become available in India.

4. Most importantly, there is no information on how Astra Zeneca will price the drug. In many developed countries where the drug is available, it is one of the most expensive drugs in the world with the cost of one vial running into several lakhs of rupees and a dose being needed at least every two to four weeks.

aHUS patients and their families should be aware that the Indian government recently expanded their Rare Disease Program to increase the grant provided under this scheme from Rs. 20 lakhs to Rs. 50 lakhs. While this may still not be enough beyond a few months, at least it is a start. aHUS is also included in the list of diseases that are covered by this program. Please see this and this for more information.

After all these years of despondence, there is finally some hope for us. Clearly, we are not out of the woods yet. But there is hope that a path will emerge soon.

Crovalimab trial in India in children and adults

Just a few weeks back, we posted this article where we alerted Indian aHUS patients to a trial on Iptacopan, an oral aHUS drug. And now there is another trial for aHUS patients for the drug Crovalimab from Roche.

Crovalimab is a complement inhibitor which can be administered to patients recently diagnosed with aHUS. The Phase III trial is for both adults and children who have not yet progressed to kidney failure (are dialysis dependent). 

Here are the details of the two trials of this new drug:

Adults and Adolescents:

Information about the trial

Participating sites & Investigators (Currently Active for Enrolment)

1. All India Institute of Medical Sciences, Delhi,  Principal Investigator: Dr Aditi Sinha

2. Medanta, The Medicity, Gurugram | Principal Investigator: Dr Sidharth Sethi

3. Sawai Man Singh (SMS) Hospital, Jaipur, Principal Investigator: Dr Dhananjai Agrawal

Children:

Information about the trial

Participating sites & Investigators (Currently Active for Enrolment)

1. All India Institute of Medical Sciences, Delhi,  Principal Investigator: Dr Aditi Sinha

2. Medanta, The Medicity, Gurugram | Principal Investigator: Dr Sidharth Sethi

This is an earnest request to all nephrologists and other doctors who come across aHUS patients in India. Please take this opportunity to enrol your patients into these trials. Until now, aHUS patients had nowhere to turn to. We no at least have trials happening in the country which should hopefully, pave the way for general availability in due course.