Novartis Wins Five Simultaneous Drug Approvals in Japan

By Pavel Ryzhov, Ph.D.

Global regulatory procedures for bringing new medicines to the market vary widely in scope and are governed by generic or direct competition and many other factors including safety and efficacy requirements. Even if a drug secures approval from the US Food and Drug Administration, it can still be years away from getting into the European or Asian markets. The reverse is also true, due to the differences in clinical trial review, and payor landscape. These regulatory considerations are routinely included in the go-to-market strategy for big multinational pharma companies. Thus, drug approvals represent a culmination of a years-long commitment to bringing advanced therapies to patients.

That’s why, when Novartis recently gained approval for five treatment options in Japan, it was a massive achievement and milestone for the company, according to its press-release, bringing the total number of approved medicines in Japan this year to seven. The approved drugs include Tabrecta™, Entresto®, Mayzent®, Enerzair® and Atectura® and they join previously approved Zolgensma (spinal muscular atrophy gene therapy) and Beovu (an anti-VEGF treatment for wet age-related macular degeneration).

Tabrecta is an oral kinase inhibitor for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC), specifically those whose tumors contain mutations leading to mesenchymal-epithelial transition (MET) exon 14 skipping. It has recently gained approval in the US.

Entresto is an oral combination drug that consists of sacubitril, an inhibitor of Zn-dependent metalloprotease neprilysin and valsartan, a blocker of angiotensin II receptor. It is prescribed for reducing the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure, among a few other heart failure indications. Entresto has been previously approved in the US in 2015.

Mayzent is a sphingosine 1-phosphate receptor modulator and an oral treatment of relapsing forms of multiple sclerosis (MS), like secondary progressive MS, and was previously approved by the FDA in 2019.

Enerzair is a triple-combination therapy asthma inhaler, that has recently obtained a recommendation for marketing authorization in the EU by European Medical Agency’s Human Medicines Committee (CHMP), but has not been approved in the US.

Similarly to Enerzair, Atectura is an asthma inhaler but only consisting of indacaterol acetate, mometasone furoate, while the former also contains glycopyrronium bromide. It has also been granted market authorization in the EU.

The five drugs that have simultaneously received approval by the Japanese Ministry of Health, Labour and Welfare (MHLW), mark an “unprecedented milestone” and are “truly novel and transformative treatments”, said Kazunari Tsunaba, Representative Director and President of Novartis Pharma. This further strengthens Novartis’ regulatory approval record and, more importantly, brings the patients timely access to these medicines.

Related Article: Bavencio Bags FDA Approval as First-line Maintenance Treatment for Urothelial Carcinoma

References

1. https://www.novartis.com/news/media-releases/novartis-receives-simultaneous-approval-five-new-products-from-japanese-ministry-health-labour-and-welfare-offering-japanese-patients-broad-range-novel

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Author

Pavel Ryzhov