Novartis receives European Commission approval for DME treatment

Novartis announced Thursday it has been granted approval from the European Commission (EC) for Beovu (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME).

This latest approval is the second indication granted by the EC, as Beovu was first approved in 2020 for the treatment of age-related macular degeneration (AMD). It applies to all of the European Union’s (EU) 27 member states as well as Norway, Iceland, and Liechtenstein, according to a news release.

Approval was based on 1-year data of the KESTREL and KITE studies, which were phase 3, randomized, and double-masked. Both trials met their primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at the first year, the release stated.

After the loading phase in both trials, 55.1% of patients in the KESTREL study and 50.3% of patients in the KITE study with a Beovu 6 mg arm stayed on a 12-week dosing interval through year 1, the company reported. Aflibercept dosing was also aligned to the approved EU label in one year of treatment.

In total, the company stated that a numerically lower proportion of patient eyes treated with Beovu had intraretinal fluid, subretinal fluid, or both by 52 weeks. This was in comparison to eyes treated with aflibercept—60.3% of patients in the KESTREL study with the Beovu arm versus 73.3% of patients with aflibercept arm; and 54.2% versus 72.9% of patients in the KITE study, respectively. Testing for statistical significant was not conducted.

“KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one,” said Jill Hopkins, SVP and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals, in a statement. “The EC approval of Beovu in DME may thus help address unmet needs.”

For both studies, the most common ocular and non-ocular adverse events (>5%) at year one were conjunctival hemorrhage, nasopharyngitis, and hypertension, the company reported.

Study results

The company also reported that, in KESTREL, intraocular inflammation (IO1) rates were 4.7% or brolucizumab 3 mg (including 1.6% retinal vasculitis, 3.7% for Beovu 6 mg (including 0.5% retinal vasculitis), and 0.5% for aflibercept 2 mg2.

Further, in KITE, IOI rates were equivalent (1.7%) between the Beovu 6 mg and aflibercept 2 mg arms, with no retinal vasculitis reported.

Retinal vascular occlusion was present in KESTREL for brolucizumab 3 mg (1.1%) and 6 mg (0.5%), and in KITE for brolucizumab and aflibercept (0.6% each), according to the company.

Investigators report that the majority of these events were manageable and resolved with routine clinical care.

In KESTREL, the percentage of patients who experienced ≥15 letter loss from baseline at year 1 was 1.6% for brolucizumab 3 mg, 0% for Beovu 6 mg and 0.5% for aflibercept. In KITE, the percentage of patients who experienced ≥15 letter loss from baseline at year 1 was 1.1% for Beovu 6 mg and 1.7% for aflibercept, the company reported.

Regulatory applications for Beovu for the treatment of DME are currently under review by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as well as the FDA in the United States.