Novartis plans for 60 regulatory filings during 2019-2021
Novartis Plans for 60 Regulatory Filings Over the Next Three Years
By Alex Keown
Novartis made the announcement today during a research and development update in London. The company said the conference provides investors with a deeper insight into its pipeline and the potential therapeutics that could be on the market over the next few years. In its announcement this morning, Novartis said the company has 26 potential blockbusters in confirmatory development and 13 projects in clinical development across Cell, Gene & Radioligand therapies.
With a bold prediction of a potential 26 blockbuster drugs, Novartis’ secondary multiple sclerosis treatment Mayzent is expected to lead the way. Mayzent (siponimod) is currently under review by the U.S. Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA). In April, Novartis released additional data from its Phase III EXPAND trial that showed siponimod-dosed patients gained a significant benefit in cognitive processing speed. That data came about one month after Novartis published data that showed multiple sclerosis drug siponimod generated significant improvements in patients, including a 21 percent decrease in the risk of disease progression. If approved, Novartis said it anticipates the launch of Mayzent in the first quarter of 2019. Mayzent would bolster its MS pipeline that is expected to see some losses due to generic competition for its blockbuster drug Gilenya.
In addition to Mayzent, Novartis pointed to several other drugs that have the potential to be blockbusters. Novartis’ ofatumumab is a next-generation B-cell depletor with a potentially favorable safety profile from faster b-cell repletion and preserved immunity, and with a convenient monthly sub-cutaneous dosing. It is also being studied as a potential therapy for multiple sclerosis. If approved, it could be seen as a rival for Roche’s Ocrevus. Ofatumumab has already been approved as a treatment for chronic lymphocytic leukemia under the brand name Arzerra.
Novartis also highlighted a few other drugs that have the potential to be blockbusters, including moderate-to-severe asthma treatment fevipiprant; nAMD treatment brolucizumab, which Novartis said has the potential to reduce treatment burden by drying the retina better with fewer injections; and in sickle cell disease, the therapeutic crizanlizumab has shown itself to be effective in clinical trials and the company anticipates regulatory filing in 2019.
During the Monday showcase, Novartis pointed to the potential launch of its therapy for spinal muscular atrophy type I, AVXS101. The company said it was on track for a launch in the first half of 2019 and clinical development is ongoing for all other SMA subtypes. Novartis gained AVXS101 through its $8.7 billion acquisition of AveXis earlier this year. Novartis said it anticipates regulatory approvals for AAVXS101 early next year in the United States, Europe and Japan.
Novartis also pointed to some other highlights in its Radioligand therapy. Last year, Novartis acquired Advanced Accelerator Applications for $3.9 billion and successfully launched Lutathera in neuroendocrine tumors (NET) and has projects in development for indications beyond NET. In October Novartis announced the acquisition of Endocyte for $2.1 billion to expand its radiopharmaceuticals business.
Novartis also announced that it is pursuing new indications for some of its established brand medications such as Cosentyx, Entresto and Gilenya. The company said Cosentyx is expected to be Novartis’ largest drug next year, with robust growth in all three approved indications.