Regulatory Index News: 20/02/2018

Welcome to your Regulatory Index News update today. Two approvals and some concern in today's digest, take a read below to see what is happening.

J&J’s schizophrenia drug under fire thanks to new label language

Janssen Pharmaceuticals received a historic FDA approval for new label language for their schizophrenia treatment, Invega Sustenna, earlier this year. The approval allowed the label to state that the drug can delay the arrest or incarceration of patients taking it and has now come under fire by mental experts as it essentially acts as a ‘get-out-of-jail-free card’. While some health experts see this reduced jail-time selling point as “depressing commentary” for mental health treatment, J&J are clear on their vision with full plans on how to take advantage of the new approval in marketing materials such as a 17-minute advertising video which has been released. The approval for the altered label was based on a study of 444 adults with schizophrenia, where all participants had been arrested at least twice in two years leading up to the trial. The trial found that Invega Sustenna delayed relapse rate of schizophrenia by 416 days on average versus 226 days in patients taking other drugs. Please click here to read more from FiercePharma's article.

FDA approves AstraZeneca’s Imfinzi in lung cancer

The FDA have approved the expansion of scope for AstraZeneca’s/ MedImmune’s immunotherapy, Imfinzi, originally approved to treat certain patients with locally-advanced or metastatic urothelial carcinoma. The drug has now been approved to treat unresectable Stage III non-small cell lung cancer (NSCLC) in patients where their disease has not progressed following platinum-based chemoradiation therapy. The basis of approval here was a Phase 3 trial (PACIFIC) which showed that the treatment led to a 11.2-month improvement in median progression-free survival (PFS) compared to the placebo. This gives patients a new option that may allow for more time without disease progression. This indication is also currently under review in the EU. Please click here to read further into this PharmaTimes' article.

EU approval for Celltrion’s Herceptin biosimilar

Celltrion Healthcare’s Herzuma (CT-P6), a Herceptin biosimilar, has been approved for use across all indications of its reference product which include treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer with HER2 over-expression or amplification. This comes after the drug was found to be highly similar to Herceptin in terms of efficacy, safety, immunogenicity, pharmacodynamics and pharmacokinetics. This is expected to be welcomed by healthcare professionals as a high quality but less economically burdening alternative to Herceptin, which had worldwide sales of $6.8billion in 2016. The biosimilar is also under review in the US. If you would like to read more on this, please click here for PharmaTimes' article. 



Max Lymbery

Date Published

20th February 2018

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