Drugs in Development: Multiple Sclerosis
A few of the drugs that are in development for multiple sclerosis in the US include tcelna, ATA188 & ATA190, NurOwn, Diroximel, Ozanimod, Ublituximab, MN-166, and CHS-131. Details on the manufacturers of these drugs and other multiple sclerosis drugs by these manufacturers have been outlined below.
Tcelna by Opexa TheraPeutics
- Tcelna is a T-cell immunotherapy that is under development for treating Secondary Progressive Multiple Sclerosis.
- Five clinical trials have been completed by the manufacturer of Tcelna, Opexa Therapeutics, for the effectiveness of the drug,
- The US FDA granted tcelna a Fast Track status due to its promising potential.
- Opexa Therapeutics does not have any fully developed multiple sclerosis drug on the market.
ATA188 and ATA190 by Atara Biotherapeutics
- Atara Biotherapeutics is developing allogeneic ATA188 and autologous ATA190 with its "complementary T-cell immunotherapy technology." Both drugs could potentially slow down or halt the development of multiple sclerosis.
- A phase 1 clinical trial testing the safety of ATA188 and ATA190 in patients with progressive multiple sclerosis began in 2017 and is expected to be completed by October 2021.
- Atara Biotherapeutics does not have any fully developed multiple sclerosis drug on the market.
NurOwn by Brainstorm Cell Therapeutics
- NurOwn is an amyotrophic lateral sclerosis therapy in its phase 3 development stage for patients with multiple sclerosis.
- NurOwn is also known as autologous MSC-NTF It is being developed by BrainStorm Cell Therapeutics.
- BrainStorm Cell Therapeutics does not have any fully developed multiple sclerosis drug on the market.
Diroximel Fumarate by Biogen
- Also known as Vumerity, diroximel fumarate is an investigational drug that reduces disease activity in patients that have been newly diagnosed with multiple sclerosis.
- A new drug application for diroximel fumarate was just accepted by the FDA in February 2019.
- Vumerity was initially developed by Alkermes but in 2017, it was licensed to Biogen.
- Natalizumab is a multiple sclerosis and Crohn's disease drug on the market that was developed by Biogen and Elan Pharmaceuticals. It is also known as TYSABRI.
- Avonex (Interferon beta-1a) is a treatment by Biogen for relapsing multiple sclerosis.
- Zinbryta (daclizumab) is a multiple sclerosis drug by Biogen and AbbVie. However, it was taken off the market in April 2018.
Ozanimod by Celgene Corporation
- Ozanimod is an oral receptor modulator developed by Celgene Corporation for treating adults with relapsing multiple sclerosis.
- In 2017, Celgene submitted a New Drug Application for ozanimod. This New Drug Application was rejected by the FDA "due to shortcomings in the preclinical and clinical pharmacology parts of its package."
- Celgene Corporation announced in March 2019 that it submitted another New Drug Application to the FDA for the drug.
- Celgene Corporation does not have any fully developed multiple sclerosis drug on the market.
Ublituximab (TG-1101) by TG Therapeutics
- Ublituximab (TG-1101) is a "monoclonal antibody [by TG Therapeutics] that targets a unique epitope on the B-lymphocyte CD20 antigen."
- Although it was developed to treat B-cell proliferative disorders, it has anti-CD20 antibodies which are effective in treating multiple sclerosis.
- Ublituximab is in its phase 3 clinical trial stage. This study is focused on patients with multiple sclerosis and hematologic malignancies.
- TG Therapeutics does not have any fully developed multiple sclerosis drug on the market.
MN-166 by MediciNova
- MN-166 (ibudilast) by Medicinova is an investigational drug for the treatment of progressive multiple sclerosis, drug addiction, ALS, and pain.
- In April 2019, Medicinova announced its commencement of a phase 2b and a phase 3 clinical trial of ibudilast in patients with amyotrophic lateral sclerosis (ALS).
- Medicinova does not have any fully developed multiple sclerosis drug on the market.
CHS-131 by Coherus BioSciences
- CHS-131 is a novel oral drug for multiple sclerosis patients.
- A phase 2b clinical trial for the efficacy of CHS-131 in patients with multiple sclerosis was done over the course of six months in 2016.
- Coherus Biosciences is still contemplating filing a New Drug Application with the FDA for CHS-131.
- Coherus Biosciences does not have any fully developed multiple sclerosis drug on the market.
OTHER DRUGS IN THE PIPELINE FOR MULTIPLE SCLEROSIS
- Ofatumumab (Arzerra) and Mayzent (siponimod) are multiple sclerosis drugs in development by Novartis AG. Mayzent was approved by the FDA in May 2019. Although Novartis AG is headquartered in Switzerland, it is a multinational company that has a large US market.
- Afinitor (everolimus), Extavia (Interferon beta-l b), Gilenya (fingolimod), and Lescol (fluvastatin sodium) are drugs for multiple sclerosis that have already been developed and marketed by Novartis.
Our first approach for this request was to find any existing documents or lists of drugs that are in development for multiple sclerosis. We examined healthcare related websites such as Medscape and Pharmaceutical Journal. Websites like MS Trust and MS Discovery offered these lists. However, we found that these lists were outdated as most of the drugs have already been released and marketed. There were only one or two drugs still being developed but since these drugs were manufactured by pharmaceutical companies outside the US, we did not include them.
Next, we focused on the best-possible sources. We specifically looked for databases with drug pipeline data. Through an advanced search on BioPharm Catalyst, we were able to find some of the drugs in development for multiple sclerosis. To verify that we were on the right track, we also reviewed the most recent clinical trials for multiple sclerosis and checked to see what drugs were being used in these trials. We focused only on clinical trials that are still ongoing or about to begin. We excluded terminated clinical trials as this could mean the drug will not be developed anymore. Through both strategies, we were able to gather nine drugs by eight companies that are still in development for multiple sclerosis.
To find the drugs for multiple sclerosis that these companies currently have on the market, we relied on their respective websites for a list of drugs they developed. In order to confirm that we did not miss any drugs, we perused their annual reports within the past few years. We also leveraged databases like CenterWatch which provided lists of drugs manufactured by several US pharmaceutical companies. The aforementioned strategies did not help in finding any information on which of these drugs might do well financially. However, the multiple sclerosis drugs in pipeline by Novartis and Biogen have more media coverage than others.