Biomedical Engineering Reference
In-Depth Information
Ozurdex
®
was significantly superior to that of a sham injection and
that the safety profile was acceptable. They particularly noted that
adverse effects other than elevated IOP were similar to sham, and
that the increases in IOP were as expected with this drug class [
36
].
The FDA granted Ozurdex
®
orphan drug status for the uveitis
indication. Approval to market Ozurdex
®
for intermediate and
posterior uveitis was granted on the basis of a supplemental NDA
submitted after the approval of Ozurdex
®
for BRVO/CRVO [
37
].
A detailed SBA for this indication was not published by the FDA.
Marketing authorizations for Ozurdex
®
in Europe were obtained
through use of the Centralized Procedure [
38
]. In the European
Public Assessment Report issued by the EMA for Ozurdex
®
, the
EMA stated that the recommendation for marketing authorization
was granted because the Committee decided that the benefits
of Ozurdex
®
are greater than its risks. The report noted that the
Ozurdex
®
injection appeared to cause only minor trauma to the eye
and that the increases in IOP were manageable [
38
].
4.2 European
Union Approvals
5 Notes (Expert Opinion)
The most important steps to ensuring the successful launch of a
new drug are very similar in both the US and the EU. Nonetheless,
an application that is deemed approvable in the US may not be
considered approvable in the EU and vice versa. One reason for this
could be that the two regions have different processes for reviewing
an application once it has been submitted, and the two mechanisms
may focus on different sets of priorities and concerns depending on
the candidate drug. This can be avoided by seeking timely advice
from both agencies throughout the development process.
In both the US and the EU, a successful application for mar-
keting approval depends on early and frequent consultation with
the appropriate contacts at both the FDA and the EMA. These
consultations should begin while the candidate drug is still under-
going preclinical testing and continue throughout every clinical
trial phase. Meetings with agency contacts will be most productive
if the objectives of the meeting are very clear, all appropriate back-
ground materials and a specific agenda are sent to the participants in
advance, and if the drug sponsor comes to the meeting with a very
specific list of questions. The drug sponsor should not ask either
agency what to do, but rather present what has already been
learned, describe what is proposed as the next step in the develop-
ment plan (provide specific protocols), and ask if the plan would be
sufficient to support a successful application. At all times it is
important to provide detailed and prompt responses to any and
all concerns and questions raised by the agencies.
