Definition
Multiple sclerosis (MS) is widely recognized as the most common neurological and inflammatory disorder of the central nervous system (CNS) in the adult population. It is a chronic, recurrent, progressive autoimmune disorder characterized by repeated episodes of inflammation of the white matter nervous tissue of the CNS. The location of the inflammation varies from person to person and from episode to episode, and as such, results in a variety of clinical symptoms. The periventricular regions, optic nerves, brainstem, cerebellum, and spinal cord are common locations for inflammation in MS. The average age for disease onset is 30 years, with women being twice as likely to develop MS compared to men.
Latest Key Takeaways
Multiple sclerosis (MS) is widely recognized as the most common neurological and inflammatory disorder of the central nervous system (CNS) in the adult population. It is a chronic, recurrent, progressive autoimmune disorder characterized by repeated episodes of inflammation of the white matter nervous tissue of the CNS. The location of the inflammation varies from person to person and from episode to episode, and as such, results in a variety of clinical symptoms. The periventricular regions, optic nerves, brainstem, cerebellum, and spinal cord are common locations for inflammation in MS. The average age for disease onset is 30 years, with women being twice as likely to develop MS compared to men.
Latest Key Takeaways
- The publisher estimates that in 2018, there were 2.1 million prevalent cases of multiple sclerosis (MS) worldwide, and forecasts that number to increase to 2.2 million prevalent cases by 2027.
- A large selection of disease-modifying therapies (DMTs) are currently available in the MS market with a sizable range of attributes, potencies, and safety profiles. Consequently, this set of DMTs typically can yield some relief from this chronic condition.
- Utilization of first-generation DMTs such as Avonex, Betaseron, Copaxone, and Rebif is declining due to their comparatively poor safety, efficacy, and administration profiles versus newer DMTs. Most are genericized, but still see some use in the first-line treatment setting, particularly for less-severe cases of MS and especially where payer pressure is involved.
- Since Ocrevus’s launch in 2017, the drug has quickly risen to realize its gold-standard potential in the wider MS field. Its efficacy is unparalleled, and coupled with its six-monthly dosing regimen, the drug is popular with patients and physicians alike. As the only approved therapy for primary progressive MS (PPMS), it has little competition in this patient segment. Furthermore, Ocrevus is increasingly being prescribed at the first and second lines of treatment in other MS subtypes, and particularly in more rapidly progressing and severe cases.
- Long-awaited decisions have come from the key patent litigation trials of former blockbuster DMTs. In 2020 it was ruled that Biogen’s ‘514 patent, protecting Tecfidera until 2028, was invalid. This paved the way for Mylan to gain FDA approval for its dimethyl fumarate generic and launch the drug in rapid succession.
- Novartis fared better in litigation trials, as a US district court upheld the validity of the Gilenya dosing regimen patent, which is set to expire in December 2027 (inclusive of the pediatric exclusivity extension). However, Novartis has previously settled agreements with some generic drug companies, and generic fingolimod will likely enter the market before the expiration of the Gilenya patent. Nevertheless, at least for the next few years, Novartis will enjoy exclusivity for its blockbuster oral MS therapy.
- Bristol Myers Squibb’s Zeposia, a sphingosine-1-phosphate (S1P) receptor modulator, was approved in 2020 for relapsing forms of multiple sclerosis (RMS), and will provide stiff competition for rival S1P drugs Gilenya and Mayzent. Meanwhile, market penetration may be difficult for Johnson & Johnson’s Ponvory, which was approved in March 2021. As another S1P receptor modulator, the drug lacks a clearly distinguished profile from its rivals.
- Another recent event in the MS space was Novartis’s anti-CD20 targeting drug Kesimpta receiving FDA approval for the treatment of RMS in adults. This positions the drug as a direct market competitor of Roche’s dominant Ocrevus, though Roche has the underserved PPMS segment contained in the Ocrevus label. Kesimpta, however, has the advantage of a more appealing subcutaneous administration route.
- High-impact upcoming events for drugs in the MS space that are expected by the end of 2021 include an EU approval decision for Vumerity and Phase II topline results for elezanumab.
Table of Contents
OVERVIEW
DISEASE BACKGROUND
TREATMENT
EPIDEMIOLOGY
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
DRUG ASSESSMENT MODEL
FUTURE TRENDS
RECENT EVENTS AND ANALYST OPINION
KEY OPINION LEADER INSIGHTS
UNMET NEEDS
LIST OF FIGURES
LIST OF TABLES
