Wednesday, May 29, 2024

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.

No comments:

Post a Comment