Pfizer Submits Marketing Authorization Applications to EMA for Somatrogon and 20-Valent Pneumococcal Conjugate Vaccine

Mar 01, 2021 11:51 CST Updated 11:51

Pfizer

Pharmaceutical R&D Developer

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

Compiled by newborn

Last Friday, Pfizer announced that the European Medicines Agency (EMA) had accepted the marketing authorization applications (MAAs) for two of its products: one is the long-acting human growth hormone (hGH) somatrogon, and the other is the 20-valent pneumococcal conjugate vaccine (20vPnC).

somatrogon

Somatrogon is a long-acting recombinant human growth hormone product administered via once-weekly injection for the treatment of pediatric patients with growth hormone deficiency (GHD). The European Commission was expected to issue its review decision in 2022.

In 2014, Pfizer and OPKO entered into a global agreement to develop and commercialize somatrogon for the treatment of growth hormone deficiency (GHD). Currently, somatrogon is under review by the U.S. FDA, with a PDUFA target date of October 2021. In January this year, the two parties submitted a marketing application for somatrogon in Japan.

If approved for market launch, somatrogon will represent a significant advancement in the treatment of growth hormone deficiency (GHD). Compared with currently available once-daily human growth hormone (hGH) products, somatrogon can substantially reduce the treatment burden, minimize disruption to patients’ daily lives, and have a positive impact on the quality of life of children with GHD.

In the European Union, the regulatory application for somatrogon was supported by results from a global Phase 3 trial. This trial evaluated the efficacy and safety of once-weekly somatrogon in children with growth hormone deficiency (GHD). The study met its primary non-inferiority endpoint: after 12 months of treatment, once-weekly somatrogon demonstrated comparable efficacy to once-daily Genotropin injections in terms of annual height velocity. Furthermore, compared with the Genotropin group, the somatrogon group showed greater improvements in height standard deviation scores at both 6 and 12 months, as well as a greater increase in height velocity at 6 months. Somatrogon was generally well tolerated in this trial, with the type, frequency, and severity of adverse events being comparable to those observed with Genotropin.

In addition, Pfizer and OPKO announced the results of study C0311002 in October 2020. This was a randomized, multicenter, crossover, open-label Phase 3 trial evaluating the treatment burden of somatrogon versus Genotropin in pediatric patients aged 3 to under 18 years with growth hormone deficiency (GHD). The results showed that the trial met its primary endpoint: after 12 weeks of treatment, once-weekly somatrogon improved the mean total score for overall life interference compared with once-daily Genotropin. Regarding key secondary endpoints, somatrogon also demonstrated overall benefits in terms of treatment experience. These data have also been submitted to the EMA.

20vPnC

20vPnC is a 20-valent pneumococcal polysaccharide conjugate vaccine indicated for adults aged 18 years and older to prevent invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes included in the vaccine. These serotypes are responsible for the majority of invasive pneumococcal diseases and pneumonia worldwide. Following the acceptance of the Marketing Authorization Application (MAA), the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has initiated the formal review process.

In the 20vPnC Marketing Authorization Application (MAA), data from the adult clinical program were included, comprising Phase I and II trials as well as three Phase III trials (NCT03760146, NCT03828617, NCT03835975). These three trials evaluated the immunogenicity and safety of 20vPnC for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes covered by the vaccine in adults aged 18 years and older. The three Phase III trials enrolled a total of more than 6,000 adult subjects aged 18 years and older, including adults aged 65 years and older, pneumococcal vaccine-naïve adults, and adults previously vaccinated with pneumococcal vaccines.

20vPnC includes the 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as well as seven additional serotypes (8, 10A, 11A, 12F, 15BC, 22F, and 33F). These 20 serotypes are currently the primary causes of pneumococcal disease worldwide. Notably, the seven additional serotypes are not included in any currently licensed pneumococcal vaccines.

Currently, 20vPnC is also undergoing priority review by the U.S. FDA, with a PDUFA target date of June 2021. In June 2020, Pfizer announced the initiation of two Phase III clinical trials of 20vPnC to evaluate the safety and efficacy of this vaccine in infants and young children.

References:

1.EMA ACCEPTS MARKETING APPLICATION FOR SOMATROGON TO TREAT PEDIATRIC PATIENTS WITH GROWTH HORMONE DEFICIENCY

2.EUROPEAN MEDICINES AGENCY ACCEPTS PFIZER’S MARKETING AUTHORIZATION APPLICATION FOR ITS INVESTIGATIONAL 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FOR ADULTS 18 YEARS OF AGE OR OLDER

*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.