Press Release: Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis...

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-- Filings are supported by Phase III ASCLEPIOS I and II studies, where

ofatumumab showed highly significant and clinically meaningful reduction

in the number of confirmed relapses, evaluated as annualized relapse rate

(ARR)1

-- Ofatumumab is a novel B-cell therapy that delivers sustained efficacy

with a favorable safety profile1

-- If approved, ofatumumab has the potential to become a first-choice

treatment for a broad RMS population and the first B-cell therapy that

can be self-administered at home using an autoinjector pen

-- Regulatory approval for ofatumumab in the US is expected in June 2020 and

in Europe by Q2 2021

Basel, February 24, 2020 -- Novartis today announced that both the US

Food and Drug Administration (FDA) and European Medicines Agency (EMA)

have accepted the company's Supplemental Biologics License Application

(sBLA) and Marketing Authorization Application (MAA), respectively, for

ofatumumab (OMB157) for the treatment of relapsing forms of multiple

sclerosis (RMS) in adults. Ofatumumab is a novel B-cell therapy that

delivers sustained efficacy with a favorable safety profile(1). If

approved, ofatumumab has the potential to become a first-choice

treatment for a broad RMS population and the first B-cell therapy that

is easy to start and manage in a monthly subcutaneous injection that can

be self-administered at home using an autoinjector pen.

The regulatory applications are based on positive data from the Phase

III ASCLEPIOS I and II studies, which investigated the efficacy and

safety of monthly subcutaneous ofatumumab 20mg versus once daily oral

Aubagio(R) * (teriflunomide) 14mg in adults with RMS(2,3). In both

head-to-head studies, ofatumumab demonstrated superiority over

Aubagio(R) in patients with RMS(1). Both studies met the primary

endpoints where ofatumumab showed a highly significant and clinically

meaningful reduction in the number of confirmed relapses, evaluated as

the annualized relapse rate (ARR)(1). Key secondary endpoints of

delaying time to confirmed disability progression (CDP) were also met(1)

. Data presented at the 35(th) Congress of the European Committee for

Treatment and Research in Multiple Sclerosis (ECTRIMS) showed that

compared to Aubagio(R), ofatumumab:

-- Reduced the ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25)

(p<0.001 in both studies) in ASCLEPIOS I and II respectively1

-- Showed highly significant suppression of both Gd+ T1 lesions and new or

enlarging T2 lesions, demonstrating a profound abrogation of new

inflammatory activity1

-- Showed a relative risk reduction of 34.4% (p=0.002) in three-month CDP

and 32.5% (p=0.012) in six-month CDP in pre-specified pooled analyses1

Overall ofatumumab, a potent, fully-human antibody targeting CD20

positive B-cells, delivered efficacy with a favorable safety profile(1)

. The safety profile of ofatumumab as seen in the ASCLEPIOS studies is

in line with the observations from Phase II results(1,4).

In addition, Novartis has completed the APLIOS study, an open-label

Phase II study, to determine the bioequivalence of subcutaneous

administration of ofatumumab via a pre-filled syringe -- as used in

ASCLEPIOS I and II -- and an autoinjector pen in patients with RMS(5).

The positive results of the study will be presented at the Americas

Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)

Forum in Florida, US. These results show that ofatumumab offers a highly

effective B-cell therapy that can be self-administered at home using a

patient-friendly autoinjector pen.

"We are excited that ofatumumab has the potential to be a powerful

first-choice treatment option for patients and physicians looking for an

impactful intervention," said Krishnan Ramanathan, Neuroscience Global

Program Head at Novartis. "With ofatumumab, we underpin our relentless

dedication to reimagine medicine for patients across the MS spectrum and

will work closely with the regulatory authorities to ensure it is

available for people living with MS as soon as possible."

Regulatory approval for ofatumumab in the US is expected in June 2020

and in Europe by Q2 2021. Novartis is committed to bringing ofatumumab

to patients worldwide and additional regulatory filings are currently

underway.

About ofatumumab

Ofatumumab is a fully human anti-CD20 monoclonal antibody (mAb)

self-administered by a once-monthly subcutaneous injection in

development for RMS. Ofatumumab works by binding to the CD20 molecule on

the B-cell surface, distinct from that of other anti-CD20 antibodies,

and induces potent B-cell lysis and depletion(4). The selective

mechanism of action and subcutaneous administration of ofatumumab allows

precise delivery to the lymph nodes, where B-cell depletion in MS is

needed, while sparing those in the spleen that help maintain protective

immunity(4,5). Once-monthly dosing of ofatumumab also allows faster

repletion of B-cells(4), and offers more flexibility as no first dose

observations or laboratory monitoring is required. Novartis obtained

rights for ofatumumab from Genmab in all indications, including MS, in

December 2015.

About ASCLEPIOS I and II studies

The ASCLEPIOS I and II studies are twin, identical design, flexible

duration (up to 30 months), double-blind, randomized, multi-center Phase

III studies evaluating the safety and efficacy of ofatumumab 20mg

monthly subcutaneous injections versus Aubagio(R) 14mg oral tablets

taken once daily in adults with RMS(2,3). The ASCLEPIOS I and II

studies enrolled 1,882 patients with MS, between the ages of 18 and 55

years, with an Expanded Disability Status Scale (EDSS) score between 0

and 5.5(2,3). The studies were conducted in over 350 sites in 37

countries. Ofatumumab demonstrated a reduction in ARR by 50.5% (0.11 vs.

0.22) and 58.5% (0.10 vs. 0.25) compared to Aubagio(R) (p<0.001 in both

studies) in ASCLEPIOS I and II respectively. It showed highly

significant suppression of both Gd+ T1 lesions and new or enlarging T2

lesions, demonstrating a profound suppression of new inflammatory

activity. Ofatumumab also showed a relative risk reduction of 34.4%

(p=0.002) in three-month CDP and 32.5% (p=0.012) in six-month CDP

compared to Aubagio(R) in pre-specified pooled analyses. Overall

ofatumumab, a potent, fully-human antibody targeting CD20 positive

B-cells, delivered efficacy with a favorable safety profile. The safety

profile of ofatumumab as seen in the ASCLEPIOS studies is in line with

the observations from Phase II results(1,4). Additional secondary

endpoints included confirmed disability improvement at six months, serum

levels of neurofilament light chain (NfL), and rate of brain volume

loss(2,3).

About APLIOS study(5)

The APLIOS study is a 12-week, open-label, Phase II bioequivalence study

to determine the bioequivalence of subcutaneous administration of

ofatumumab via a pre-filled syringe -- as used in ASCLEPIOS I and II --

and an autoinjector pen in patients with RMS and to evaluate the onset

of B-cell depletion with ofatumumab subcutaneous monthly injections.

Patients were randomized according to injection device and site

including the abdomen and the thigh. B-cell depletion was measured nine

times over 12 weeks. The positive results of the study will be presented

at the Americas Committee for Treatment and Research in Multiple

Sclerosis (ACTRIMS) Forum in Florida, US.

About Multiple Sclerosis

MS disrupts the normal functioning of the brain, optic nerves and spinal

cord through inflammation and tissue loss(6). MS, which affects

approximately 2.3 million people worldwide(7), is often characterized

into three forms: primary progressive MS (PPMS)(8), relapsing-remitting

MS (RRMS), and secondary progressive multiple sclerosis (SPMS), which

follows from an initial RRMS course and is characterized by physical and

cognitive changes over time, in presence or absence of relapses, leading

to a progressive accumulation of neurological disability(9).

Approximately 85% of patients initially present with relapsing forms of

MS(7).

About Novartis in MS

In addition to ofatumumab, the Novartis MS portfolio also includes

Gilenya(R) (fingolimod, an S1P modulator), which is indicated in the EU

for the treatment of adult patients and children and adolescents 10

years of age and older with RRMS. In the US, Gilenya is approved for the

treatment of adults and pediatric patients aged 10 years and older with

RMS, to include CIS(++), relapsing remitting disease and active

secondary progressive disease.

Mayzent is a sphingosine 1-phosphate receptor modulator that selectively

binds to S1P1 and S1P5 receptors. In the US, Mayzent is approved for the

treatment of relapsing forms of MS, to include CIS(++), relapsing

remitting disease and active secondary progressive disease. In the EU,

Mayzent is indicated for the treatment of adult patients with SPMS with

active disease evidenced by relapsing or imaging features of

inflammatory activity. In November 2019, Novartis received approval from

the Australian Therapeutic Goods Administration (TGA) for Mayzent for

adult patients with SPMS.

Extavia(R) (interferon beta-1b for subcutaneous injection) is approved

in the US for RMS, to include CIS(++), relapsing remitting disease and

active secondary progressive disease. In Europe, Extavia is approved to

treat people with RRMS, SPMS with active disease and people who have had

a single clinical event suggestive of MS.

In the US, the Sandoz Division of Novartis markets Glatopa(R)

(glatiramer acetate injection) 20mg/mL and 40mg/mL, generic versions of

Teva's glatiramer acetate.

Disclaimer

This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

1995. Forward-looking statements can generally be identified by words

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February 24, 2020 01:15 ET (06:15 GMT)