CHMP Adopts Positive Opinion for Zoledronic Acid
15 March 2012
EMA/176371/2012
Committee for Medicinal Products for Human Use (CHMP)
Summary of opinion 1 (initial authorisation)
Zoledronic Acid Teva Pharma
Zoledronic acid
On 15 March 2012, the Committee for Medicinal Products for Human
Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for
the medicinal product Zoledronic
Acid Teva Pharma, 5 mg, solution for infusion intended for the
treatment of osteoporosis (in post-
menopausal women and in men at increased risk of fracture),
treatment of osteoporosis associated
with long-term systemic glucocorticoid therapy (in post-menopausal
women and in men at increased
risk of fracture) and for the treatment of Paget’s disease of
the bone in adults.
The applicant for this medicinal product is Teva Pharma B.V. They
may request a re-examination of
any CHMP opinion, provided they notify the European Medicines
Agency in writing of their intention
within 15 days of receipt of the opinion.
The active substance of Zoledronic Acid Teva Pharma is zoledronic
acid (as monohydrate), a
bisphosphonate (M05BA08). Zoledronic acid acts primarily on the
bone; it is an inhibitor of osteoclast-
mediated bone resorption. The selective action of bisphosphonates
on bone is based on their high
affinity for mineralised bone. Zoledronic acid treatment rapidly
reduces the rate of bone turnover. The
positive effect of zoledronic acid on various types of bone
fractures, bone mineral density, bone
histology, bone turnover markers, standing height and days of
disability was demonstrated in patients
with osteoporosis. In Paget’s disease, bone of normal quality
was found in responding patients after
treatment with zoledronic acid.
The most common side effects are fever, myalgia, flu-like symptoms,
arthralgia and headache.
Zoledronic acid Teva Pharma is a generic of Aclasta, which has been
authorised in the EU since
15 April 2005. Studies have demonstrated the satisfactory quality
of Zoledronic acid Teva Pharma. This
product is administered intravenously and is 100% bioavailable;
therefore, a bioequivalence study
versus the reference product Aclasta was not required. A question
and answer document on generic
medicines can be found here.
1
Summaries of positive opinion are published without prejudice
to the Commission decision, which will normally be issued
67 days from adoption of the opinion.
Zoledronic Acid Teva Pharma
EMA/176371/2012 Page 2/2
A pharmacovigilance plan for Zoledronic Acid Teva Pharma will be
implemented as part of the
marketing authorisation.
The approved indication is:
Treatment of osteoporosis
? in post-menopausal women
? in men
at increased risk of fracture
Treatment of osteoporosis associated with long-term systemic
glucocorticoid therapy
? in post-menopausal women
? in men
at increased risk of fracture
Treatment of Paget’s disease of the bone in adults
It is proposed that for the treatment of Paget’s disease,
Zoledronic acid Teva Pharma be prescribed
only by physicians with experience in the treatment of
Paget’s disease of the bone.
Detailed recommendations for the use of this product will be
described in the summary of product
characteristics (SmPC), which will be published in the European
public assessment report (EPAR) and
made available in all official European Union languages after the
marketing authorisation has been
granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data
submitted, considers there to be a
favourable benefit-to-risk balance for Zoledronic Acid Teva Pharma
and therefore recommends the
granting of the marketing authorisation.
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© European Medicines Agency, 2012. Reproduction is authorised
provided the source is acknowledged.
Posted: March 2012
