Merck's Antifungal Drug Noxafil Receives New Pediatric Indications in China for Prevention and Treatment of Invasive Fungal Infections

China Finance and Economics News, December 10th: MSD announced today that the new indications for its antifungal drug Noxafil (posaconazole enteric-coated tablets, posaconazole injection) in two dosage forms have been approved by the Center for Drug Evaluation of the National Medical Products Administration. The population for prevention and treatment has been expanded to include pediatric patients, providing a new option for safe and effective treatment plans for antifungal prevention and treatment in children.

Among them, posaconazole enteric-coated tablets have been approved for the prevention of invasive aspergillosis and candidiasis in adult and pediatric patients ≥2 years old with a body weight greater than 40kg who are at risk due to severe immunodeficiency, as well as for the treatment of invasive aspergillosis in patients ≥13 years old; posaconazole injection has been approved for the prevention of invasive aspergillosis and candidiasis in adult and pediatric patients ≥2 years old who are at risk due to severe immunodeficiency, as well as for the treatment of invasive aspergillosis in patients ≥13 years old.

Invasive Fungal Infections Severely Threaten Patients' Health and Have Become a Global Public Health IssueInvasive fungal infections pose a serious threat to the life and health of patients and have become a global public health issue. In recent years, with the continuous increase in medical interventions, the widespread use of broad-spectrum antimicrobial drugs and glucocorticoids, as well as advancements in organ transplantation and catheterization techniques, the risk of fungal opportunistic infections has significantly increased. Children account for a considerable proportion of these cases, particularly among pediatric hematopoietic stem cell transplant recipients in an immunosuppressed state, where the incidence of invasive fungal infections can reach 25.3%. The overall mortality rate for children with fungal infections is relatively high, with the mortality rate for invasive mold disease being approximately 50%. Active antifungal prophylaxis can significantly reduce the incidence of invasive fungal infections and improve patient outcomes.

"Children with invasive fungal infections often present with low specificity in clinical manifestations, which may only show as fever and are difficult to distinguish from symptoms of other underlying diseases; the prognosis of infection is poor. Taking invasive pulmonary fungal infection (IPFI) as an example, pediatric patients with IPFI have a worse prognosis compared to bacterial infections, with higher mortality rates. Early diagnosis and treatment are crucial to improving outcomes," said Professor Chen Jing from the Shanghai Children's Medical Center affiliated with the Shanghai Jiao Tong University School of Medicine. Due to the particularities of pediatric patients, diagnostic and therapeutic options are relatively limited. The recent approval of posaconazole enteric-coated tablets and posaconazole injection for pediatric indications will provide new options for the prevention and treatment of invasive aspergillosis infections in children, safeguarding the health of more young patients.

Anna Tian, Senior Vice President of MSD Global and President of MSD China, stated that MSD has a strong foundation in the anti-infective field, with a comprehensive product pipeline covering antifungal, antibacterial, and antiviral solutions. Since its introduction to China in 2013, Noxafil has become an important weapon in clinical treatment against fungal infections. The recent approval of its pediatric indication is expected to further improve the diagnosis and treatment of invasive fungal infections in children, bringing hope to more families.

"For pediatric infectious disease diagnosis and treatment, the challenges faced by clinicians are often more severe." Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China R&D Center, stated that this approval further expands the indications portfolio of Noxafil in China, supporting clinical needs for antifungal treatment across different age groups. MSD will continue to focus on meeting patients' medical needs and explore more innovative treatment solutions in the anti-infective field.

Currently, Noxafil has three formulations approved in China, including posaconazole oral suspension, posaconazole enteric-coated tablets, and posaconazole injection. All three formulations have been included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List (2023)."