Sanofi’s Toujeo heads latest crop of CHMP opinions

Sanofi’s long-acting follow-up to blockbuster basal insulin Lantus has been recommended for approval in the EU, just a few days after getting a green light from the US FDA.

Toujeo is a higher-strength formulation of $7 billion-a-year Lantus (insulin glargine) that provides the same blood glucose control as its predecessor but is less prone to causing steep reductions in blood glucose, known as hypoglycaemic episodes.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Toujeo following its last meeting on 23-26 February, when it also gave its backing to a new lung cancer drug from Novartis and a rare kidney disease therapy from Japan’s Otsuka.

Sanofi is due to lose patent protection for Lantus this year and Toujeo is a key part of its strategy to defend its diabetes franchise. The CHMP issued a positive opinion recommending the approval of Toujeo for patients with type 1 diabetes, as well as those with type 2 diabetes who can no longer control their blood glucose levels using oral antidiabetic drugs (OADs) alone.

The task facing Sanofi’s new chief executive Olivier Brandicourt will be to make the hypoglycaemia reduction a compelling reason to switch from Lantus, which is facing competition from biosimilars – including Eli Lilly/Boehringer Ingelheim’s Abasria, which won CHMP backing last September – as well as other long-acting rivals such as Novo Nordisk’s Tresiba (insulin degludec).

Zykadia backed for NSCLC

The CHMP also issued a positive opinion for Novartis’ Zykadia (ceritinib) as a second-line treatment for patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) therapy. Somewhere between 2 and 7 per cent of NSCLC patients have the ALK mutation.

The green light for use of the drug in patients who have failed treatment with Pfizer’s Xalkori (crizotinib) is conditional upon the completion of additional studies, including an ongoing phase III trial due to generate data within the next three years.

Zykadia was approved for marketing in the US last April and has been tipped to become a $300 million-plus product by 2018, behind Xalkori, which is predicted to bring in $800 million in that year. Last year, Pfizer booked $438 million from sales of its product, a rise of 55 per cent over 2013, while Zykadia brought in $31 million in its first few months on sale.

Otsuka’s Jinarc

A positive opinion for Otsuka’s Jinarc (tolvaptan) means it is on course to become the first drug specifically approved in Europe to treat autosomal dominant polycystic kidney disease (ADPKD), a rare condition affecting around 4 in 10,000 people in the EU.

Jinarc – a vasopressin-2 receptor antagonist – is indicated for patients with ADPKD with chronic kidney disease stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. It is already used in a different dosage – as Samsca – to treat abnormally low sodium levels in the blood.

The CHMP has, however, recommended additional monitoring of the risk of liver damage with Jinarc, as recent studies found a greater number of people with serious liver adverse effects on the drug compared to placebo.

In the US, the FDA decided against approval of tolvaptan in ADPKD in 2013, on the recommendation of an advisory committee which said the company had not provided enough evidence of its safety and efficacy. Last year Otsuka agreed to carry out another phase III trial to try to allay those concerns.

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