May approvals spotlight the rise of pediatric drugs under policy support in China
Danni Yin ·06/16/2022
China NMPA Approval Tracker

Chinese regulators gave their nod to more pediatric medicines in May 2022, a move in line with the country’s commitment to supporting the development of these drugs.

Bayer’s rivaroxaban oral suspension, Novartis’s Promacta (eltrombopag), Santen’s Verkazia (Ciclosporin Eye Drops (III)) and GSK’s HPV vaccine Cervarix, were all cleared in May for pediatric patients. These treatments could secure market exclusivity for up to 12 months thanks to a recent policy. Pediatric medicines are also granted priority review, as regulators reiterated in the document.

While fewer drugs were approved in the month compared to March and April, the indications expanded beyond oncology to include ophthalmology, hematology and infectious diseases.

Pediatric drugs in the spotlight

Pediatric drugs stood out in May. Novartis won a broader label for Promacta in China to treat children aged between 6 and 11 with chronic immune thrombocytopenia, seven years after the FDA granted approval for the same indication. Promacta was first approved for adults patients in China in 2017.

Bayer’s rivaroxaban oral suspension was approved to treat venous thromboembolism (VTE) and reduce the risk of VTE for anyone under the age of 18, including newborns. This came five months after the FDA clearance.

Also approved this month were Santen’s Verkazia for severe vernal keratoconjunctivitis in children and adolescents over four years of age, as well as GSK’s HPV vaccine Cervarix for girls aged nine to 14.

These approvals came as favorable policies to support the development and approval of pediatric drugs are bearing fruit. Since the beginning of 2022, 13 drugs have won approval for pediatric indications or expanded the label to include children.

In 2016, the CDE issued its principles for the priority review of clinically urgently needed pediatric drug and the first five pediatric drugs were granted approval.

Then in 2019, the Drug Administration Law pledged to “encourage research and development and innovation of pediatric drugs, support the development of new varieties, dosage forms and strengths of pediatric drugs according to pediatric physiological requirements, and prioritizes review and approval of pediatric drugs.”

Revision of the Implementation Regulations on the Drug Administration Law in May 2022 also set an exclusivity period of up to 12 months for new pediatric drugs.

Since 2013, the CDE has issued 12 pediatric-related guidelines to encourage clinical trials. In the priority review process, regulators take 130 working days to look at the NDA of a pediatric drug, 70 working days shorter than the usual process.

Encouraged by these policies, many drugmakers have begun to enroll children in initial registration clinical studies or focus on developing drugs for that patient group. As of December 2021, at least 150 pediatric drugs were granted priority review and nearly 70 of them were approved via priority review.

Oral diabetes drugs filed for NDA

In May, Novo Nordisk filled its NDA submission for semaglutide oral tablets, which will be marketed as Rybelsus. The drug’s injection dosage form Ozempic has been approved since April 2021 for the treatment of type 2 diabetes.

Rybelsus was the only oral GLP-1R drug in the global market for type 2 diabetes and has captured the market with its superior glucose-lowering and weight-lowering efficacy since its launch. In addition, semaglutide is approved for obesity in the U.S., with clinical data showing weight loss results.

Several GLP-1 receptor agonists (GLP-1RA) have been marketed in China so far, ranging from daily to weekly formulations, from injectable to oral formulations, from peptides to small molecules, and from single-target GLP-1RA to dual-target and multi-target GLP-1 receptor agonists. The development of the GLP-1 field has never stopped.

Last month, Eli Lilly's first-in-class, once-weekly dual GIP/GLP-1 receptor agonist Mounjaro (tirzepatide) was approved by the FDA for the treatment of type 2 diabetes and will compete head-to-head with semaglutide. Eli Lilly says it will consider marketing the drug under a separate brand for obesity, like how Novo Nordisk splits semaglutide into two separate brands: Ozempic for diabetes and Wegovy for obesity.

Keywords: May approvals Chinese regulators the rise of pediatric drugs
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