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PIASKY (CROVALIMAB-AKKZ)
PIASKY (generic name: CROVALIMAB-AKKZ) is a Complement C5 Inhibitor [EPC] drug developed by GENENTECH INC. It is currently FDA-approved.
Crovalimab is being studied in a Phase II clinical trial for the treatment of Antiphospholipid Syndrome. The trial is comparing the efficacy of Crovalimab to a placebo and VKA (Vitamin K Antagonist) in patients with Antiphospholipid Syndrome.
At a glance
| Generic name | CROVALIMAB-AKKZ |
|---|---|
| Sponsor | GENENTECH INC |
| Drug class | Complement C5 Inhibitor [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: SERIOUS MENINGOCOCCAL INFECTIONS PIASKY, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of PIASKY, unless the risks of delaying therapy with PIASKY outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving PIASKY are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, PIASKY is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called PIASKY REMS [see Warnings and Precautions (5.2) ] . WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning. PIASKY increases the risk of serious and life-threatening infections caused by Neisseria meningitidis . Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of PIASKY, unless the risks of delaying PIASKY outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor ( 5.1 ). Patients receiving PIASKY are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected ( 5.1 ). PIASKY is available only through a restricted program called the PIASKY REMS ( 5.2 )
Common side effects
- Infusion-related reaction
- Respiratory tract infection
- Viral infection
- Type III hypersensitivity reaction
- Peripheral edema
- Headache
Serious adverse events
- Type III hypersensitivity reaction
- Epistaxis
- Pneumonia
- Infusion related reaction
- Pyelonephritis
- COVID-19
- Hypovolemic shock
- Nasopharyngitis
- Urinary tract infection
- Grade 3 axonal neuropathy
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PIASKY CI brief — competitive landscape report
- PIASKY updates RSS · CI watch RSS
- GENENTECH INC portfolio CI
Frequently asked questions about PIASKY
What is PIASKY?
PIASKY (CROVALIMAB-AKKZ) is a Complement C5 Inhibitor [EPC] drug developed by GENENTECH INC.
Who makes PIASKY?
PIASKY is developed and marketed by GENENTECH INC (see full GENENTECH INC pipeline at /company/roche).
What is the generic name of PIASKY?
CROVALIMAB-AKKZ is the generic (nonproprietary) name of PIASKY.
What drug class is PIASKY in?
PIASKY belongs to the Complement C5 Inhibitor [EPC] class. See all Complement C5 Inhibitor [EPC] drugs at /class/complement-c5-inhibitor-epc.
What development phase is PIASKY in?
PIASKY is FDA-approved (marketed).
What are the side effects of PIASKY?
Common side effects of PIASKY include Infusion-related reaction, Respiratory tract infection, Viral infection, Type III hypersensitivity reaction, Peripheral edema, Headache. Serious adverse events: Type III hypersensitivity reaction, Epistaxis, Pneumonia, Infusion related reaction.
Related
- Drug class: All Complement C5 Inhibitor [EPC] drugs
- Manufacturer: GENENTECH INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing