Sunday, August 1, 2021

MHRA approves label extension for Vertex’s Kaftrio combo

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a label extension for Vertex’s cystic fibrosis (CF) treatment Kaftrio in combination with ivacaftor.

Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is now available in Great Britain for the treatment of CF in all patients aged 12 years and older, who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

In April, the European Commission (EC) also approved this label extension for Vertex’s triple combination CF treatment.

This allowed eligible patients in the Republic of Ireland, Northern Ireland, Denmark and Luxembourg to gain access to the expanded indication for Kaftrio thank to long-term reimbursement agreements.

The label extension approval was supported by results of three Phase III studies in people aged 12 years and older with CF, which evaluated the treatment regimen in patients with a range of mutations.

Vertex utilized the EC decision reliance procedure in Great Britain – following this MHRA approval, the long-term reimbursement agreements that Vertex has in place in England, Scotland and Wales means that the patients who are now eligible for Kaftrio will get access ‘shortly’.

Source link

Stay Connected


Latest Articles

Need to create vigilance and awareness on zoonotic diseases: India’s Health Minister

The COVID-19 pandemic has highlighted the need of creating vigilance and awareness on zoonotic diseases, informed Union Health Minister Mansukh Mandaviya while virtually inaugurating...

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...