23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human
genetics and biopharmaceutical company, released a new Simvastatin
Medication Insight report as part of its 23andMe+ membership
service that reports on a person's likelihood of experiencing side
effects from this commonly prescribed statin drug.
The new Medication Insight report is part of a suite of 23andMe
reports that examine how a person's genetics may impact their
response to certain medications and their chance of experiencing
possible side effects. These are the first and only
direct-to-consumer pharmacogenetic reports authorized by the FDA.
Under the recent FDA 510(k) clearance, which modifies the labeling
of the previously authorized SLCO1B1 Drug Transport report, there
is no additional confirmatory testing requirement for this report,
and a healthcare provider can use the results from the report to
guide care. Simvastatin is a commonly prescribed statin drug used
to lower cholesterol in the blood and reduce the risk of heart
attacks, strokes, or other heart problems.
"People respond differently to the same medication due to many
factors such as age, weight, liver and kidney function, diet, or
even other medications they might be taking,” said Dr. Noura
Abul-Husn, 23andMe's Vice President of Genomic Health. “But we have
also known for some time that genetic differences play a major role
in the effectiveness of many medicines. In some cases, those
differences lead to medication side effects or adverse
reactions.”
This new Simvastatin Medication Insight report* available for
23andMe+ members looks at how individuals respond to simvastatin,
known by the brand names such as Flolipid® and Zocor®. The insight
report provides clear information about whether an individual has
an increased chance of experiencing side effects.
One in four Americans over 40 use a statin to lower their
cholesterol. About 8 million people in the US were prescribed the
statin simvastatin in 2020, amounting to about 36 million
prescriptions, making it among the most prescribed medications in
the United States.
Genetic differences in the SLCO1B1 gene affect a protein
involved in moving some medications, including statins, from the
blood to the liver, where they are processed and removed from the
body. When the gene function is reduced, statin levels in the blood
rise, increasing the likelihood of side effects like muscle pain,
weakness, or both, a condition known as myopathy.
Muscle pain or weakness is one of the most common side effects
of statins, including simvastatin. About one in ten people on
statins discontinue its use, and most, about 60 percent, report
that they stopped because of muscle pain. Having one or two copies
of the SLCO1B1 variant included in 23andMe's report increases the
risk of developing simvastatin-associated myopathy, muscle pain and
weakness, from two to six times. Importantly, studies have shown
that patients who received SLCO1B1 genotype-guided therapy were
more likely to take their medication, had improved perceptions of
statin therapy, and had better health outcomes.
About half of the people in the United States use at least one
prescription drug in any given month. Millions of these individuals
have one of the common genetic variants that impact how they
process those medications, whether a blood thinner, an
antidepressant, or pain medication. The list of medications that
the Food and Drug Administration labels with a known genetic
variant that impacts their efficacy now includes hundreds of drugs,
and it continues to grow. Knowing beforehand whether a prescription
drug is likely to work, or trigger an adverse reaction, offers a
tremendous public health benefit.
The 23andMe+ membership offers information about how your DNA
may affect the processing of almost two dozen medications used in
treatments that range from depression, high cholesterol, and
anti-clotting drugs to certain medications used in chemotherapy.
The reports look specifically at how variants in three genes —
CYP2C19, DPYD, and SLCO1B1 — affect the body’s ability to
metabolize or transport those medications.
Remember that other factors besides your genetics can also
affect how your body processes medications, and customers should
not change their medications without first consulting their
healthcare provider.
About 23andMe23andMe is a genetics-led consumer
healthcare and biopharmaceutical company empowering a healthier
future. For more information, please visit www.23andMe.com.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended, including, without
limitation, statements regarding the future performance of
23andMe’s businesses in consumer genetics and therapeutics and the
growth and potential of its proprietary research platform. All
statements, other than statements of historical fact, included or
incorporated in this press release, including statements regarding
23andMe’s products, strategy, financial position, funding for
continued operations, cash reserves, projected costs, plans, and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," “predicts,” "continue," "will," “schedule,” and "would"
or, in each case, their negative or other variations or comparable
terminology, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements are predictions
based on 23andMe’s current expectations and projections about
future events and various assumptions. 23andMe cannot guarantee
that it will actually achieve the plans, intentions, or
expectations disclosed in its forward-looking statements and you
should not place undue reliance on 23andMe’s forward-looking
statements. These forward-looking statements involve a number of
risks, uncertainties (many of which are beyond the control of
23andMe), or other assumptions that may cause actual results or
performance to differ materially from those expressed or implied by
these forward-looking statements. The forward-looking statements
contained herein are also subject generally to other risks and
uncertainties that are described from time to time in the Company’s
filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K, as filed with the Securities and Exchange
Commission, and as revised and updated by our Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K. The statements made
herein are made as of the date of this press release and, except as
may be required by law, 23andMe undertakes no obligation to update
them, whether as a result of new information, developments, or
otherwise.
Important Test Information*23andMe PGS
Pharmacogenetics reports: The 23andMe test uses qualitative
genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in
the DPYD gene and 1 variant in the SLCO1B1 gene in the genomic DNA
of adults from saliva for the purpose of reporting and interpreting
information about the processing of certain therapeutics to inform
discussions with a healthcare professional. It does not describe if
a person will or will not respond to a particular therapeutic. Our
CYP2C19 Pharmacogenetics report provides certain information about
variants associated with metabolism of some therapeutics and
provides interpretive drug information regarding the potential
effect of citalopram and clopidogrel therapy. Our SLCO1B1
Pharmacogenetics report provides certain information about variants
associated with the processing of some therapeutics and provides
interpretive drug information regarding the potential effect of
simvastatin therapy. Our DPYD Pharmacogenetics report does not
describe the association between detected variants and any specific
therapeutic. Results for DPYD and certain CYP2C19 results should be
confirmed by an independent genetic test prescribed by your own
healthcare provider before taking any medical action.
Warning: Test information should not be used to
start, stop, or change any course of treatment and does not test
for all possible variants that may affect metabolism or protein
function. The PGS test is not a substitute for visits to a
healthcare professional. Making changes to your current regimen can
lead to harmful side effects or reduced intended benefits of your
medication, therefore consult with your healthcare professional
before taking any medical action. For important information and
limitations regarding Pharmacogenetic reports, visit
www.23andme.com/test-info.
ContactsInvestor Relations Contact:
investors@23andMe.comMedia Contact: press@23andMe.com
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