In an interview with PharmaShots, Monica Mann, Head of Global Medical, Multiple Sclerosis at Biogen shares her views on the Plegridy and how it works on MS patients. She also shed light on the approval of the therapy in the US and EU.

Shots:

• The approval of Plegridy (IM) by the EC and the US FDA is based on data demonstrating bioequivalence with the SC administration and overall similar safety profiles in healthy volunteers
• The IM route of administration of Plegridy has already launched in Germany, UK, Ireland, and the US. Biogen is actively working to launch the IM route of administration of Plegridy in countries throughout the EU and in the US
• Plegridy is the only pegylated beta interferon approved for use in relapsing or relapsing-remitting MS and is dosed once every two weeks.

Tuba:  Tell us more about Relapsing-Remitting Multiple Sclerosis?

Monica:  Relapsing-remitting multiple sclerosis (RRMS) is the most common type of multiple sclerosis (MS), accounting for approximately 85 percent of diagnoses.1

We continue to learn more about how the heterogeneous nature of MS and health inequities affect different populations. For example, we know that Hispanic Americans with MS are younger at age of onset and diagnosis, with higher levels of cognitive and manual dexterity impairment when compared to their white non-Hispanic counterparts. Additionally, twice as many Black people with MS have substantial MS-related disability compared to white patients.2,3

People who have RRMS have relapses of new or worsening neurological symptoms with periods of remission occurring in between.1 MS is a heterogeneous disease and each patient's journey and symptoms can vary greatly. Biogen has a broad portfolio of MS therapies designed to address the different needs of patients.

Source: Businesswire

Tuba:  Can we discuss more about the mechanism of action for Plegridy and how it works on MS patients?

Monica: PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of relapsing forms of MS. PLEGRIDY is the only pegylated beta interferon approved for use in relapsing or relapsing-remitting MS and is dosed once every two weeks. Although there is a large body of evidence on how interferon beta's impact the immune system, the exact mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.

PLEGRIDY builds on our experience with interferons which dates back to the 1990s when we launched AVONEX (interferon beta-1a) in 1996 as a once-a-week injection. We then continued our work in MS and introduced PLEGRIDY which through the process of pegylation enables it to be dosed every two weeks.

Tuba:  Why there is a need to develop IM injection if Biogen already had SC formulation for Plegridy? Does this improve patient adherence or efficacy/ safety?

Monica: As a leader in MS, Biogen is constantly innovating across its robust MS portfolio to help address the individual needs of the community.  Part of that innovation involves providing more treatment choices, including new routes of administration.

Biogen developed an intramuscular (IM) administration of PLEGRIDY based on feedback from MS physicians, who expressed the desire for an IM route of administration in addition to the subcutaneous (SC) administration to provide a choice for their patients. Injection site reactions may occur with the subcutaneous administration of PLEGRIDY. The availability of a new IM route of administration offers individuals living with relapsing or relapsing-remitting MS an additional choice combining the safety and efficacy of PLEGRIDY, with the potential to significantly reduce injection site reactions.

Tuba:  Can we discuss more about the clinical studies which lead to the approval of Plegridy in the EU and U.S.?

Monica:  PLEGRIDY was first approved in the EU and U.S. in 2014, based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 patients with relapsing-remitting MS.2 PLEGRIDY has been shown to significantly reduce important measures of relapsing MS disease activity and has a well-characterized safety and efficacy profile. Some side effects observed in these trials include liver problems, depression, and injection site reactions.

The recent approvals of PLEGRIDY for IM administration by the European Commission (EC) and U.S. Food and Drug Administration (FDA) are based on data demonstrating bioequivalence with the SC administration and overall similar safety profiles in healthy volunteers.3

Tuba:  Can you throw some light on the clinical studies their design and how these trials were instrumental in approval?

Monica: The approvals of PLEGRIDY for IM administration were based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. Bioequivalence between the two routes of administration was confirmed and data show that participants receiving PLEGRIDY through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration (14.4 percent vs. 32.1 percent). The overall safety profiles were similar and there were no new safety signals observed.4

Tuba:  When can we expect the launch of Plegridy IM formulation in the EU?  Where do you plan to launch Plegridy in EU? When will it be available in the U.S.?

Monica: The IM route of administration of PLEGRIDY has already launched in Germany, the UK, Ireland, and the U.S.

Biogen is actively working to launch the IM route of administration of PLEGRIDY in countries throughout the EU and in the U.S.

PLEGRIDY is currently approved in over 60 countries including the U.S., Canada, Australia and Switzerland, and across the European Union. Over 61,000 people worldwide have been treated with PLEGRIDY, with over 120,000 patient years of experience, based on prescription data.5

Tuba:  Are you planning to explore other geographies except Europe and the US?

Monica: Biogen plans to file in other countries around the world.

Tuba:  Is Biogen planning to assess Plegridy in other indications beyond MS?

Monica: There are no current plans to assess PLEGRIDY in indications outside of relapsing-remitting MS.

Tuba:  Can we discuss on any patient support programs Biogen plans to launch in EU? Can you discuss little about already running programs in the US or other geographies?

Monica: The launch of the IM route of administration of PLEGRIDY will include the adaptation of existing AVONEX and PLEGRIDY Patient Support Programs in the EU, including digital patient materials and video tools to help facilitate education about this new route of administration.

In the U.S., Biogen Support Services offers financial assistance, help with navigating insurance, and additional information on treatment. 

Tuba:  Is Biogen planning to launch any digital initiatives to increase patient adherence or for HCP educations?

Monica:

As part of Biogen's ongoing commitment to members of the MS community, we've developed digital tools and resources to help patients and caregivers manage the demands of daily life. One of these offerings is Biogen's Cleo app (called 'Aby' in the U.S.), which empowers people with MS to access news and information from the comfort of their home, with options to journal and track symptoms, explore exercise programs, practice guided meditation or chat live with a nurse.

In addition, new innovative tools using smart devices are designed to support the patient-physician relationship CogEval is a free, easy-to-use iPad app developed by Biogen that is designed to help HCP's routinely evaluate cognitive function in people with MS. Based on the Symbol Digit Modalities Test (SDMT), CogEval provides a two-minute assessment of attention, psychomotor speed, visual processing, and working memory, and is completed by patients in a healthcare office setting. CogEval is available in 39 countries and 22 languages.6

References:

1. MS International Federation. Types of MS. Available at https://www.msif.org/about-ms/types-of-ms/. 
2. Rivera VM et al. Socio-demographic and Clinical Characteristics of Patients With Multiple Sclerosis by Race and Ethnicity (NARCRMS Registry). Poster presented at 8th Annual Joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS), 2020.
3. Gray-Roncal, KM et al. African Americans with Multiple Sclerosis have Greater Disability and Lower Socio-Economic Status than Caucasian Americans. Poster presented at 8th Annual Joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS), 2020.
4. Calabresi PA et al. Peginterferon Beta-1a Provides Improvements in Clinical and Radiological Disease Activity in Relapsing-Remitting Multiple Sclerosis: Year 1 Finding from the Phase 3 ADVANCE. Poster presented at 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis, 2013.
5. Important Safety Information and full Prescribing Information, including Medication Guide for PLEGRIDY in the U.S.
6. Zhao Y, et al. A phase 1, open-label, crossover study to evaluate the bioequivalence of intramuscular and subcutaneous peginterferon beta-1a in healthy volunteers. Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis - 2020 Forum; 2020 Feb 27-29; West Palm Beach, Florida, USA.
7. Combined post-marketing data based on prescriptions for PLEGRIDY as of September 30, 2020.
8. Kalb R, Beier M, Benedict RH, Charvet L, Costello K, Feinstein A, Gingold J, Goverover Y, Halper J, Harris C, Kostich L, Krupp L, Lathi E, LaRocca N, Thrower B, DeLuca J. Recommendations for cognitive screening and management in multiple sclerosis care. Mult Scler. 2018 Nov;24(13):1665-1680. doi: 10.1177/1352458518803785. Epub 2018 Oct 10.

Main Image Source: Best Medicine by Renown Health

About Author:

Monica Mann is Head of Global Medical in Multiple Sclerosis at Biogen. She has 18 years of experience in neuroscience, immunology, and CNS diseases.

Related Post: ViewPoints Interview: ViiV Healthcare's Dr. Kimberly Smith Shares Insight on the Data Presented at CROI 2021