More treatment options for PNH…entry of 'Piasky' imminent

MFDS is conducting the final review…'Piasky' is expected to be commercialized in the second half of this year

'Fabhalta' entered drug price negotiations…anticipated to be included to the reimbursement list

The entry 'Piasky,' a new PNH drug, into the Korean market is imminent.

 

According to industry sources, Roche Korea's Piasky (crovalimab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH), is undergoing final review for approval by the Ministry of Food and Drug Safety (MFDS).

 

It is expected to be officially approved in the second half of this year.

 

Piasky received the U.S.

 

Food and Drug Administration (FDA) approval in June 2024.

 

Then, it was commercialized in Europe in August of the same year.

 

In February 2024, Piasky was designated as an orphan drug in South Korea.

 

Discovered by Japan's Chugai Pharmaceutical and developed by Roche, crovalimab is a type of new anti-complement (C5) antibody.

 

Low-dose subcutaneous administration every four weeks enables circulation of the drug in the blood, thereby repeatedly inhibiting the complement.

 

Piasky's potential was confirmed based on the Phase 3 COMMODORE 2 study, which directly compared the drug to AstraZeneca's 'Soliris (eculizumab).' The study results showed that subcutaneously injected crovalimab provides disease control.

 

The safety of the drug was non-inferior compared to Soliris, a standard therapy that is administered intravenously every two weeks.

 

In the clinical study, adverse reactions occurred in 78% of the crovalimab group and 80% of the eculizumab group.

 

The most common adverse reactions were infusion-related reactions.

 

Based on the efficacy and the safety data secured from a separately conducted Phase 3 COMMODORE 1 study, patients with PNH who switched from complement C5 inhibitors that are approved and in use to crovalimab also showed a stable effectiveness profile.

 

Meanwhile, competition in the market for PNH is expected to intensify.

 

AstraZeneca has launched Ultomiris (ravulizumab) as a follow-up drug to Soliris.

 

The European patent for Soliris expired in 2023, while the U.S.

 

patents are set to expire in 207.

 

Unlike Soliris, which is intravenously injected every two weeks, Ultomiris offers an expanded administration interval of once every eight weeks.

 

Novartis obtained the U.S.

 

approval of 'Fabhalta (iptacopan),' an orally administered treatment for PNH.

 

Fabhalta is a Factor B inhibitor that acts proximally in the immune system's alternative complement pathway, providing comprehensive control of red blood cell (RBC) destruction.

 

Fabhalta is currently undergoing drug price negotiations with the National Health Insurance Service (NHIS).

 

Once an agreement is reached, this drug will be included in the national health insurance list.

 

Additionally, 'Epysqli,' Samsung Biepis' biosimilar to Soliris, has been commercialized in South Korea.

 

It was the first case of Soliris biosimilars to receive domestic approval, and Samsung Bioepis also obtained approval in Europe last year.

 

Dr.

 

Jang Jun Ho, professor at Samsung Medical Center Seoul, said, "When C5 inhibitors were introduced, experts viewed that it would bring a paradigm shift to the PNH treatment.

 

However, C5 inhibitors are limited in controlling extravascular hemolysis (EVH).

 

Thus, we have high hopes for new treatment options."