TGA approves Celltrion’s Regkirona

By Megan Brodie 3 years ago | In Products
  • 3 years ago

6 December 2021

Celltrion’s REGKIRONA (regdanvimab) has been granted provisional approval as a treatment for COVID-19 – the fifth treatment to be approved for use in Australia.

The monoclonal antibody intravenous treatment was approved for mild-to-moderate COVID-19 in infected adults after the TGA took 65 working days to make a decision – the same length of time it took to approve GSK’s XEVUDY (sotrovimab) although longer than the five days it took to approve Australia’s first Covid treatment, Gilead’s VEKLURY (remdesivir) in July 2020.

The TGA has since also approved Roche’s ACTEMRA (tocilizumab) and RONAPREVE (casirivimab + imdevimab) while a further three treatments are under evaluation.

Regkirona has received market authorisation in Europe and been granted regulatory approval in the Republic of Korea and emergency use authorisations in Indonesia and Brazil.

Pfizer’s COMIRNATY Covid vaccine was approved for use in five to 11-year-olds over the weekend, with Health Minister Greg Hunt saying Moderna is not far behind as the TGA continues to evaluate its second mRNA vaccine for use in children.

ATAGI is now considering the rollout of Comirnaty, the Government having ordered sufficient supply for all Aussie children plus booster doses. The first shipment is due to arrive early January.

“The TGA is also currently evaluating an application from Moderna for its COVID-19 vaccine to be used in Australia for children aged 6 to 11 and the Government already has supply deals in place to make it available should it be approved by the TGA and recommended by ATAGI,” Hunt said on Sunday.

TGA boss John Skerritt said the regulator had “essentially finished our evaluation of Moderna”.

“We’ve gone back to the company and the usual process is we look at it, we go to our committee, they always, as committees of experts have and we want them to, they’ll always have some questions and comments.

“We’re hopeful that Moderna will come back to us in the coming days and a decision will be able to be made about the Moderna booster. But as I say, the ball is in Moderna’s court.”

Approximately 2.3 million children aged 5 to 11 in Australia will be eligible for the Pfizer Covid vaccine, which will be distributed through GPs, Aboriginal Health Services, community pharmacies and State and Territory clinics. Packaging will be differentiated by orange-capped vials instead of grey or purple capped vials.

“The next thing is, in terms of our vaccines, for example, if there were paediatric boosters required, because of the depth of contracts we have, we are in a position to meet all of the needs under all of the scenarios in Australia,” Hunt said.

“We have 51 million Novavax that are available, subject to approval, we have 60 million Pfizer that are available during the course of 2022 if, for example, there was a third dose for children, a fourth dose for everybody. We’ve prepared for those scenarios. We have another 15 million Moderna that are coming, and paediatric Moderna is also being considered.”

Aussie kids should all have the opportunity to receive a Covid vaccine in the lead up to, and in parallel with, school returning in 2022.

©MedNews 2021

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