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DIR Return to: KESIMPTA (ofatumumab)
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#Post#: 136--------------------------------------------------
Ofatumumab
By: agate Date: January 25, 2014, 11:47 pm
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Ofatumumab has reached only Phase 2 but here it is, a new drug
that just might work.
From PubMed, January 24, 2014:
[quote]Neurology. 2014 Jan 22.
Safety and efficacy of ofatumumab in relapsing-remitting
multiple sclerosis: A phase 2 study
Sorensen PS, Lisby S, Grove R, Derosier F, Shackelford S,
Havrdova E, Drulovic J, Filippi M.
Author information
From the Danish Multiple Sclerosis Center (P.S.S.),
Rigshospitalet, Copenhagen; Genmab (S.L.), Copenhagen, Denmark;
GlaxoSmithKline (R.G.), Uxbridge, Middlesex, UK; GlaxoSmithKline
(F.D.), Research Triangle Park; GlaxoSmithKline (S.S.), Raleigh,
NC; Charles University (E.H.), Prague, Czech Republic; School of
Medicine University of Belgrade (J.D.), Serbia; and San Raffaele
Scientific Institute and Vita-Salute San Raffaele University
(M.F.), Milan, Italy.
OBJECTIVES:
We present the first study to explore safety and efficacy of the
human CD20 monoclonal antibody ofatumumab in relapsing-remitting
multiple sclerosis (RRMS).
METHODS:
In this randomized, double-blind, placebo-controlled study,
patients received 2 ofatumumab infusions (100 mg, 300 mg, or 700
mg) or placebo 2 weeks apart. At week 24, patients received
alternate treatment. Safety and efficacy were assessed.
RESULTS:
Thirty-eight patients were randomized (ofatumumab/placebo, n =
26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the
study. Two patients in the 300-mg group withdrew from the study
because of adverse events. No unexpected safety signals emerged.
Infusion-related reactions were common on the first infusion day
but not observed on the second infusion day. None of the
patients developed human anti-human antibodies. Ofatumumab was
associated with profound selective reduction of B cells as
measured by CD19+ expression. New brain MRI lesion activity was
suppressed (>99%) in the first 24 weeks after ofatumumab
administration (all doses), with statistically significant
reductions (p < 0.001) favoring ofatumumab found in new T1
gadolinium-enhancing lesions, total enhancing T1 lesions, and
new and/or enlarging T2 lesions.
CONCLUSIONS:
Ofatumumab (up to 700 mg) given 2 weeks apart was not associated
with any unexpected safety concerns and was well tolerated in
patients with RRMS. MRI data suggest a clinically meaningful
effect of ofatumumab for all doses studied. Results warrant
further exploration of ofatumumab in RRMS.
CLASSIFICATION OF EVIDENCE:
This study provides Class II evidence that in patients with
RRMS, ofatumumab compared with placebo does not increase the
number of serious adverse events and decreases the number of new
MRI lesions.
PMID: 24453078[/quote]
The abstract can be seen here
HTML http://www.ncbi.nlm.nih.gov/pubmed/24453078.
#Post#: 916--------------------------------------------------
Novartis to buy ofatumumab from GlaxoSmithKline
By: agate Date: August 28, 2015, 7:51 pm
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From the New York Times, August 21, 2015:
[quote]Novartis to Buy Multiple Sclerosis Drug From Glaxo
By AMIE TSANG and ANDREW POLLACK
Novartis bolstered its portfolio of multiple sclerosis
treatments on Friday by agreeing to buy an experimental drug
from GlaxoSmithKline for up to $1 billion, the company said.
Novartis, the Swiss pharmaceutical giant, acquired the rights
this year to use the drug, ofatumumab, to treat cancer, and
sells it under the name Arzerra. This was part of a broader swap
of assets completed in March, in which Novartis took over
Glaxo’s cancer drugs and Glaxo took on much of Novartis’s
vaccine business.
The deal announced on Friday gives Novartis all remaining rights
to ofatumumab, which is being developed to treat relapsing,
remitting multiple sclerosis and other autoimmune conditions.
Having the rights under one ownership would avoid the
complications that could arise from having two companies selling
the same drug for different uses. The deal also bolsters a
portfolio of drugs Novartis is developing for multiple
sclerosis, centered around its blockbuster pill Gilenya.
Novartis will pay $300 million upfront to Glaxo and another $200
million once late-stage clinical trials start. Novartis would
make payments of up to $534 million on top of that, depending on
whether development targets are reached. The company will also
pay royalties of up to 12 percent to Glaxo on any future net
sales of the drug.
“Novartis is pleased to further reinforce our commitment to
neuroscience and to add an exciting new treatment to our strong
MS portfolio,” David Epstein, the division head of Novartis
Pharmaceuticals, said in a news release.
In addition to Gilenya, Novartis sells a multiple sclerosis drug
called Extavia and recently began marketing a generic version of
Teva’s Copaxone, one of the most widely used drugs for the
disease. It also has some other drugs in development. Gilenya
could lose patent protection starting in 2019. So filling the
loss could be another reason for Novartis to want a new drug.
But the market for multiple sclerosis drugs is crowded, which
could limit the sales any new drug like ofatumumab could have.
Moreover, ofatumumab is only now ready to enter late-stage
clinical trials, putting it a couple of years behind
ocrelizumab, a similar drug being developed by Roche.
Both drugs deplete B cells, which are white blood cells that are
part of the immune system. B cells are necessary to fight
infections, but if they go awry, they can contribute to
autoimmune diseases like multiple sclerosis or to lymphomas.
Both drugs bind to the same molecule on the surface of B cells —
known as CD20 — as Roche’s big-selling cancer drug Rituxan.
Rituxan is not approved for multiple sclerosis, but it is
approved to treat rheumatoid arthritis, another autoimmune
disease.
Ofatumumab, a type of protein called a monoclonal antibody, was
developed initially by Genmab, a Danish biotechnology company,
which receives royalties on sales.
David Redfern, the chief strategy officer at Glaxo, said in a
news release that the sale would allow the company to focus on
core areas, including H.I.V., oncology and vaccines.
“We are pleased to have completed this transaction to divest the
remaining rights in ofatumumab, crystallizing significant
additional value for G.S.K. shareholders,” Mr. Redfern said.
The deal is expected to be completed by the end of the
year.[/quote]
#Post#: 2064--------------------------------------------------
Re: (Abst.) Subcutaneous ofatumumab in patients w/RRMS: The MIRR
OR study
By: agate Date: April 27, 2018, 7:28 pm
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From PubMed, April 27, 2018--"Subcutaneous ofatumumab in
patients with RRMS: The MIRROR study":
HTML https://www.ncbi.nlm.nih.gov/pubmed/29695594
#Post#: 2635--------------------------------------------------
Market share drama with ofatumumab a new player
By: agate Date: August 30, 2019, 10:03 am
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A couple of drug companies are competing with each other. It's
Ocrevus against ofatumumab according to this press release from
Reuters (August 29, 2019)--"Novartis Takes Aim at Roche's Star
MS Drug":
HTML https://reut.rs/2ZttMEj
#Post#: 2652--------------------------------------------------
(ECTRIMS) Ofatumumab may be competing with ocrelizumab
By: agate Date: September 16, 2019, 5:22 pm
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From Medscape (September 16, 2019)--"Ofatumumab impresses in MS:
Competition with ocrelizumab soon?"
HTML https://www.medscape.com/viewarticle/918478#vp_1
#Post#: 2788--------------------------------------------------
Update on ofatumumab (OMB157)
By: agate Date: January 22, 2020, 1:32 am
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An update on ofatumumab--from Nasdaq.com (January 21, 2020),
"Novartis gets approval for MS drug Mayzent in Europe." (The
article contains information about ofatumumab.)
HTML https://www.nasdaq.com/articles/novartis-nvs-gets-approval-for-ms-drug-mayzent-in-europe-2020-01-21
#Post#: 2831--------------------------------------------------
(ACTRIMS) Ofatumumab self-injector pen results equivalent to inf
usion...
By: agate Date: March 2, 2020, 11:57 pm
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From Multiple Sclerosis News Today, a report from the annual
ACTRIMS conference held February 27-29, 2020, "Ofatumumab
self-injector pen results equivalent to infusion, trial shows":
HTML http://bit.ly/39uyXFq
#Post#: 2988--------------------------------------------------
(NEJM abstract) Ofatumumab shows better results than Aubagio
By: agate Date: August 6, 2020, 10:01 am
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From the New England Journal of Medicine (August 6,
2020)--"Ofatumumab versus Teriflunomide in Multiple Sclerosis":
HTML https://www.nejm.org/doi/full/10.1056/NEJMoa1917246?query=TOC
It might be worth noting that the study was funded by Novartis.
#Post#: 3001--------------------------------------------------
FDA approval of Kesimpta (ofatumumab)
By: agate Date: August 21, 2020, 11:48 am
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Another MS drug to add to the collection of FDA-approved MS
treatments--a press release from Novartis, dated August 20,
2020:
HTML https://bit.ly/2QfChfG
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