LONDON, Aug. 17, 2020
/PRNewswire/ -- BTG Specialty Pharmaceuticals, a division of
Boston Scientific (NYSE:BSX), today announced the European
Medicines Agency (EMA) has accepted for review a Marketing
Authorisation Application (MAA) for Voraxaze®
(glucarpidase). BTG Specialty Pharmaceuticals is seeking marketing
authorization of Voraxaze® for the treatment of adults
and children (from 28 days of age) at risk of methotrexate toxicity
due to delayed methotrexate elimination.
The MAA for Voraxaze® is based on clinical data as
well as real world experience in the US, where glucarpidase was
approved by the FDA in 2012. Since its launch in the US, an
estimated 2,867 patients have been treated with
Voraxaze®. The efficacy of Voraxaze® has been
evaluated in four open-label multi-center studies in patients with
delayed methotrexate elimination due to renal dysfunction. In 169
patients with methotrexate concentrations measured by
chromatographic methods, a median reduction of > 98% in
methotrexate concentration occurred within 15 minutes following
Voraxaze® administration.
The EMA will review the application under the centralized
marketing authorization procedure. If approved Voraxaze®
would receive marketing authorization in all member states of the
European Union (EU), as well as
in Iceland, Liechtenstein and Norway.
"While Voraxaze® has been available in Europe on a named patient basis for eight
years, we're eager to do more to educate physicians about the
potential for Voraxaze® to help cancer patients around
the world suffering the toxic effects of methotrexate," said
Anthony Higham, President of BTG
Specialty Pharmaceuticals. "This filing is a first step toward a
marketing authorisation that would allow us to speak with European
clinicians about treating this condition."
Voraxaze® is also being independently studied to
explore whether routinely giving Voraxaze® in
combination with high-dose methotrexate might alleviate toxicity,
manage the risk to patients and help them to complete therapy.
Enrollment in these studies is ongoing. For more information about
these studies, or to contact an investigator about participation,
please visit https://clinicaltrials.gov/ct2/show/NCT03684980 or
https://clinicaltrials.gov/ct2/show/NCT03960177.
About BTG Specialty Pharmaceuticals
BTG Specialty
Pharmaceuticals, a division of Boston Scientific, provides rescue
medicines that counteract the potentially life-threatening effects
associated with exposure or overexposure to certain toxins. These
acute care products are typically used in emergency rooms and
intensive care units to treat patients for whom there are limited
or no existing treatment options. We are dedicated to delivering
quality medicines that make a real difference to patients and their
families through the development, manufacture, and
commercialization of pharmaceutical products. To learn more about
BTG Pharmaceuticals, please visit: btgsp.com.
For further information contact:
Chris Sampson, Corporate Communications
Director
chris.sampson@btgsp.com; Mobile: +44 (0)7773 251 178
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of
1934. Forward-looking statements may be identified by words
like "anticipate," "expect," "project," "believe," "plan,"
"estimate," "intend" and similar words. These forward-looking
statements are based on our beliefs, assumptions and estimates
using information available to us at the time and are not intended
to be guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding our business plans and product performance and
impact. If our underlying assumptions turn out to be
incorrect, or if certain risks or uncertainties materialize, actual
results could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These
factors, in some cases, have affected and in the future (together
with other factors) could affect our ability to implement our
business strategy and may cause actual results to differ materially
from those contemplated by the statements expressed in this press
release. As a result, readers are cautioned not to place
undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends;
intellectual property; litigation; financial market conditions; and
future business decisions made by us and our competitors. All
of these factors are difficult or impossible to predict accurately
and many of them are beyond our control. For a further list
and description of these and other important risks and
uncertainties that may affect our future operations, see Part I,
Item 1A – Risk Factors in our most recent Annual
Report on Form 10-K filed with the Securities and Exchange
Commission, which we may update in Part II, Item 1A – Risk
Factors in Quarterly Reports on Form 10-Q we have filed or
will file hereafter. We disclaim any intention or obligation
to publicly update or revise any forward-looking statements to
reflect any change in our expectations or in events, conditions or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary
statement is applicable to all forward-looking statements contained
in this document.
US INDICATION AND LIMITATIONS OF USE
- Voraxaze® is a carboxypeptidase indicated to
reduce toxic plasma methotrexate concentration (greater than 1
micromole per liter) in adult and pediatric patients with delayed
methotrexate clearance (plasma methotrexate concentrations greater
than 2 standard deviations of the mean methotrexate excretion curve
specific for the dose of methotrexate administered) due to impaired
renal function
- Limitations of Use: Voraxaze® is not
recommended for use in patients who exhibit the expected clearance
and expected plasma methotrexate concentration. Reducing plasma
methotrexate concentration in these patients may result in
subtherapeutic exposure to methotrexate
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Serious Hypersensitivity Reactions
- Serious hypersensitivity reactions, including anaphylactic
reactions, may occur. Serious hypersensitivity reactions occurred
in less than 1% of patients
Monitoring Methotrexate Concentration/Interference with
Assay
- Methotrexate concentrations within 48 hours following
Voraxaze® administration can only be reliably measured by a
chromatographic method due to interference from metabolites.
Measurement of methotrexate concentrations within 48 hours of
Voraxaze® administration using immunoassays results in an
overestimation of the methotrexate concentration
ADVERSE REACTIONS
- In clinical trials, the most common related adverse events
(occurring in >1% of patients) were paresthesia, flushing,
nausea and/or vomiting, hypotension and headache
DRUG INTERACTIONS
- Voraxaze® can decrease leucovorin
concentration, which may decrease the effect of leucovorin rescue
unless leucovorin is dosed as recommended, and may also reduce the
concentrations other folate analogs or folate analog metabolic
inhibitors
Please see full Prescribing Information.
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SOURCE BTG Specialty Pharmaceuticals