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Sales of Biocon's itolizumab surge as phase-4 clinical trials begin

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.

Biocon | Medicines

Sohini Das & Samreen Ahmad  |  Mumbai/Bengaluru 

The government is now trying to understand how long it will take before the drug’s production can start in India
The company had received an emergency approval from the Drugs Controller General of India (DCGI) in early July to market the novel biologic drug

Biocon’s repurposed psoriasis drug itolizumab has seen sevenfold jump in sales after it got an emergency use authorisation for Covid-19 treatment. The drug, however, is yet to be a part of the clinical management protocol of the health ministry for treatment of Covid-19, which implies that the government has not yet recommended it as an effective treatment.

With Phase-4 clinical trials on, sales may see a further uptick if the data supports it helps Covid-19 patients, said experts. The data from market research firm AIOCD AWACS showed that volumes shot up seven 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. Most patients require four vials for Covid-19 treatment, taking the cost of the therapy to Rs 32,000. In a few cases, a patient might need two more vials.

To repurpose the drug for Covid-19, the previous trial was done on a cohort of 30 patients suffering from moderate to severe acute respiratory disorder syndrome due to Covid-19. Of them, 20 received itolizumab and 10 received standard care. The 20 who were administered itolizumab recovered fully, the firm said. Three of the 10 patients under standard care died.

After many experts pointed out that the study was conducted on limited number of patients, has started a Phase-4 post marketing surveillance of the drug on a pool of 300 patients that will 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.

“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,

Satyanarayana Mysore, head of department of interventional pulmonology, Manipal Hospitals, who used the drug on Covid-19 patients said the use of the drug would rise if more supporting data emerges. Mysore used the drug on two patients when Roche’s tocilizumab was not available. “Both responded well. But two is a small number,” Mysore said.

Shaw had earlier said sees itolizumab as a blockbuster opportunity for the firm and has been working towards ramping up its capacity.

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First Published: Mon, October 05 2020. 21:04 IST