Soliris (brand name for the drug Eculizumab from Alexion Pharmaceuticals, now acquired by Astra Zeneca) was finally approved by the Indian drug control body, Central Drugs Standard Control Organization (CDSCO) yesterday.
The drug was advised for approval by the Experts Committee in May last year. The approval finally came yesterday. This is very welcome news for patients afflicted by life-changing diseases such as Atypical Hemolytic Uremic Syndrome (aHUS).
This clears the way for Astra Zeneca to start marketing and selling the drug in the country.
What remains to be seen though - and this is critical for a country like India - is what the drug will be priced at by the company. This is what will dictate if anything at all changes for aHUS patients. If the drug is priced even close to what it is priced at in developed countries, this approval does not mean anything at all. At least for most aHUS patients.
A lot of the discussion around this drug often centres around patients who need it short term. While there are patients who need it short term - some cancer patients, patients with certain conditions and even some aHUS patients with a certain set of mutations - the vast majority of aHUS patients are affected by mutations like those in the Complement Factor H (CFH). These patients would need the drug long term, potentially life long.
The Indian Government's Rare Disease Program provides a grant of Rupees Fifty Lakh (5 million) to rare disease patients which, at the current rates in developed countries, will barely fund the drug for a few months. What happens after that?
So, while aHUS patients in India do have a reason to cheer news of this approval, we cannot start celebrating yet. News on pricing of this drug is the next most critical aspect that we now await.
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