The Medicines and Healthcare products Regulatory Agency (MHRA)
has today (8 November 2023) authorised via a national application
route, a new indication for the diabetes medicine, Mounjaro
(tirzepatide), for weight loss and weight management in adults
aged 18 and over.
Mounjaro is now authorised for adult patients with a BMI of
30kg/m² or more (obesity), as well as those with a BMI between
27-30kg/m² (overweight) who also have weight-related health
problems such as prediabetes, high blood pressure, high
cholesterol, or heart problems.
The medicine is to be used together with a reduced-calorie diet
and increased physical activity.
The active ingredient in this treatment, tirzepatide, works by
regulating a patient’s appetite so they feel full, making them
feel less hungry and experience fewer food cravings.
Mounjaro is available for weight management as a pre-filled
injection pen filled with 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and
15mg of tirzepatide, injected under the skin of a patient’s
stomach area, thigh or upper arm.
The starting dose is 2.5mg once a week for four weeks, increasing
to 5mg once a week. The dose may then be increased in at least
4-week intervals up to the maximum dose of 15mg once weekly, if
recommended by the patient’s doctor.
Obese or overweight female patients using oral contraceptives
should consider also using a barrier method of contraception
(e.g., a condom) or switching to a non-oral contraceptive method
for 4 weeks after starting Mounjaro and for 4 weeks after each
increase in dose as Mounjaro may affect how well the
contraceptive pill works in these patients.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access, said:
We have prioritised rapid assessment of this new indication for
Mounjaro, given the public health importance of access to new
medicines to help tackle obesity.
We have drawn on advice from the independent Commission on Human
Medicines in coming to our decision, and as with all products,
will keep the safety of Mounjaro under close review.
The new weight management indication is based on the results of
two international, randomised double-blind, placebo-controlled
clinical trials, SURMOUNT-1 and SURMOUNT-2, in overweight and
obese adult patients with and without diabetes.
The studies showed that patients who were treated with
tirzepatide had a significant weight loss over time compared to
patients who took a placebo.
In SURMOUNT-1, 2,539 obese or overweight adults with at least one
weight-related complication (that was not diabetes) were given
either weekly 5mg, 10mg or 15 mg tirzepatide, or a placebo over a
72-week period. The average percentage change in weight over the
trial period was -16.0% for the 5mg dose, -21.4% for the 10mg
dose, -22.5% for the 15mg dose and -2.4% for the placebo. In
addition, 89.4% (5 mg), 96.2% (10 mg) and 96.3% (15 mg) of
patients taking tirzepatide lost at least 5% of their body weight
compared to 27.9% of those taking the placebo.
In SURMOUNT-2, 938 obese or overweight adults with Type-2
diabetes were given either weekly 10mg or 15mg tirzepatide or a
placebo over a 72-week period. Mean percentage change in weight
over the trial period was -13.4% for the 10mg dose, -15.7% for
the 15mg dose and -3.3% for the placebo. In addition, 81.6% (10
mg) and 86.4% (15 mg) of patients taking tirzepatide lost at
least 5% of their body weight compared to 30.6% of those taking
the placebo.
The most common side effects of the medicine are nausea,
diarrhoea, vomiting (which usually goes away over time), and
constipation. Low blood sugar (hypoglycaemia) is also very common
in patients with diabetes. Symptoms of this can include headache,
drowsiness, weakness, dizziness, feeling hungry, confusion,
irritability, fast heartbeat and sweating.
As with any medicine, the MHRA will keep the safety and
effectiveness of Mounjaro under close review. Anyone who suspects
they are having a side effect from this medicine are encouraged
to talk to their doctor, pharmacist or nurse and report it
directly to the Yellow Card scheme, either through the website
(https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
-
The new indication was granted on 8 November 2023 to Eli
Lilly Nederland B.V
-
More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will
be published on the MHRA Products
website within 7 days of approval.
-
For more information about the SURMOUNT studies, see the
Summary of Products Characteristics.
-
For more information on obesity and overweight
see: Obesity
- NHS (www.nhs.uk)
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