Among nine endorsements for drugs in total, it recommended that the EU Commission (EC) grant a marketing authorization for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use in people from 18 to 50 years of age as primary vaccination.
Valneva champions the traditional approach of its COVID-19 vaccine: with VLA2001 being the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against the virus in Europe.
It is the sixth vaccine recommended in the EU for protection against the virus.
In May, the EC announced its intent to terminate the Advanced Purchase Agreement (APA) given that the vaccine had not received marketing authorization from the EMA (under the terms of the APA). While Valenva has proposed a remediation plan and provided required additional information to the European Medicines Agency (EMA) – again under the conditions of the APA – it noted in a statement published earlier this month that volume indications may not be sufficient to maintain the APA.
Thomas Lingelbach, CEO of Valneva, in reaction to the CHMP recommendation, said: “We hope that the EC and its member states will recognize the potential advantages of an inactivated vaccine and make a meaningful order, since we have clear evidence that Europeans are seeking a more traditional vaccine technology.”
Gene therapy treatment for hemophilia A
The CHMP also advised a conditional marketing authorization for BioMarin’s Roctavian (valoctocogene roxaparvovec), the first gene therapy to treat severe hemophilia A, a rare inherited bleeding disorder caused by lack of factor VIII.
The therapy was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs
The official EC approval is anticipated for Q3 2022, said the Californian biotech.
Spotlight on biosimilars
And two biosimilar candidates were given the thumbs up by the EMA committee as well, with positive opinions for Celltrion Healthcare’s bevacizumab candidate (Vegzelma; CT-P16) and Formycon’s prospective ranibizumab product (FYB201).
Vegzelma references Avastin and, if approved, would be used in the treatment of several types of cancer, including metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.
The positive opinion for the bevacizumab candidate is based on evidence from a Phase 3 study that established comparable safety, efficacy, pharmacokinetic profiles between CT-P16 and the EU-approved version of Avastin in patients with metastatic or recurrent nonsquamous non–small cell lung cancer. CT-P16 was found to be well tolerated by patients and demonstrated biosimilarity between the biosimilar and reference product.
FYB201 is a biosimilar to Lucentis. It was recommended for approval in the EU for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious ocular diseases such as diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), macular edema due to retinal vein occlusion (branch RVO or central RVO) and choroidal neovascularization (CNV).
The CHMP recommendation is based on an in-depth evaluation of a comprehensive set of data for comparative analytical characterization and commercial-scale manufacturing, said Formycon. In a randomized, double-blind, multicenter, parallel-group Phase III study, FYB201 was said to demonstrate comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Lucentis (ranibizumab) in patients with age-related neovascular (wet) macular degeneration.
The developer said the EU marketing authorization for the biosimilar is expected at the end of August.