Cresemba, Pfizer Korea's antifungal drug, approved

Lower mortality than Vfend, FDA approval in 2015

Pfizer Korea obtained the product license of the antifungal drug Cresemba (Isavuconazole Sulfate) in Korea.

 

The drug is expected to have a lower mortality rate than Pfizer's Vfend.

 

The Ministry of Food and Drug Safety approved on the 29th the sale of 'Cresemba capsule 100mg' and 'Cresemba injection 200mg' of Pfizer Korea.

 

Cresemba is licensed for the treatment of invasive aspergillosis in adults 18 years of age and older and for invasive hair fungus in which Amphotericin B is not suitable for adults 18 years of age or older.

 

The FDA approved this drug in March 2015.

 

Cresemba is a drug jointly developed by Switzerland's Basilea and Japan's Astellas.

 

Pfizer holds the EU release rights and the Asia-Pacific rights, including Korea.

 

Astellas was approved in the United States and Japan.

 

The drug has been shown to have a lower mortality rate than Voriconazole (generic for Vfend) in clinical trials in 516 patients with invasive aspergillosis.

 

The mortality from all causes at 42 days was 18.6% (48/258) in the Isabuconazole group and 20.2% (52/258) in the Voriconazole group.

 

Aspergillosis is a disease caused by a respiratory infection caused by a fungus called Aspergillus, and occurs when immunity is compromised due to leukemia or chemotherapy.

 

Symptoms include chills, bleeding, chest pain and shortness of breath.

 

Particularly invasive, the infection spread systemically can cause tissue damage, thrombosis, etc.

 

due to impaired blood supply, severe sepsis can cause death.

 

Voriconazole is the generic for Vfend sold by Pfizer.

 

Vfend recorded annual sales of about ₩10 billion (Reference: IQVIA) in Korea.

 

However, in the case of Vfend, Chong Kun Dang turned into a competitive system with the introduction of Vorico, the first generic in 2017.

 

Cresemba is emerging as a new alternative to Vfend.

 

Meanwhile, the MFDS approved MSD Korea's new AIDS treatment drug, Delstrigo (Doravirine-Lamivudine -Tenofovir disoproxil fumarate).