Biocon re-purposed psoriasis drug itolizumab has seen a seven-fold jump in sales after it got an emergency use authorisation from the drug regulator for use in treating Covid-19. The drug, however, is yet to be a part of the clinical management protocol of the health ministry's treatment of Covid19.
With phase 4 clinical trials now on, the sales may see a further uptick if data supports its use on Covid-19 patients, said experts.
Data from market research firm AIOCD AWACS showed that the volumes shot up 7 times in August (350 units) from just 50 units in July when it received the approval. In June the drug did not show sales.
In India, Itolizumab, known by the brand name ALZUMAb, has been priced at Rs 8,000 per vial with most patients requiring four vials taking the total cost of the therapy to Rs 32,000. In a few cases, however, a patient might need a second dose of two more vials. The drug is manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility in Bengaluru.
The company had received an emergency approval from the Drugs Controller General of India (DCGI) in early July to market the novel biologic drug for treatment of patients with moderate to severe Covid-19 complications.
The drug, however, failed to make it to the clinical management protocol of the health ministry, which, in turn implies that the government does not yet recommend it as effective treatment.
To repurpose the drug for Covid-19 treatment, the earlier trial was done on a cohort of 30 patients who were suffering from moderate to severe ARDS (acute respiratory disorder syndrome) due to Sars-Cov-2 infection. Of the 30 patients, 20 received Itolizumab and 10 received standard of care.
While the 20 patients who were administered Itolizumab recovered fully and were discharged from hospital, said the company, in the other arm of 10 patients, three out of 10 patients in the control arm with the standard of care died.
After many experts pointed out that the study was conducted on limited number of patients, Biocon has now already started a phase 4 post marketing surveillance of the drug which will at least take a couple of months to complete. A Phase 4 study is a follow up on real world evidence on the efficacy and safety of a drug. It is done to corroborate the data that a company gets in the earlier trials.
The Bengaluru-based company is carrying out the phase 4 trial on a pool of 300 patients at around 25-30 centers across India and has brought on board an international Clinical Research Organization to drive the study.
“It is a requirement from a regulatory point of view. When we did a proof of concept study, we got the emergency use authorisation because it is already an approved drug and has a lot of safety data,” said Kiran Mazumdar Shaw, executive chairperson, Biocon. The company had developed and launched itolizumab in 2013 in India to treat moderate to severe plaque psoriasis.
Experts like Satyanarayana Mysore, head of the Department of Interventional Pulmonology, Manipal Hospitals, who have also used the drug on Covid-19 patients feel that once more data emerges on the use of the drug, it will be used more.
Mysore said that he had used the drug on a couple of patients when Roche's tocilizumab was not available easily. "Both the patients had responded well. But two patients is a very small number and now tocilizumab is also readily available," Mysore said.
He, however, pointed out that unlike tocilizumab, which specifically blocks interluken 6 (IL-6) or cytokines, theoretically Biocon's itolizumab works on the root cause of Il6 production and may limit the production. Many Covid-19 patients get into severe phases of the disease when their body's immune system behaves abnormally and a cytokine release syndrome is triggered which leads to inflammation.
"Itolizumab may also address some underlying connective tissue disorders. However, we would need more medical evidence," Mysore said.
Shaw had earlier told Business Standard that Biocon sees itolizumab as a blockbuster opportunity for the company and has been working towards ramping up internal capacity to meet the rising demand.
Biocon’s US Partner Equillium also recently announced it has completed a pre-investigational new drug meeting with the USFDA on the drug and the US regulator provided positive feedback supporting Equillium’s clinical development plans for evaluating itolizumab as a potential treatment for patients hospitalised with Covid-19.
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