Palynziq

For phenylketonuria (PKU). BLA 761079, held by Biomarin Pharm. Pegvaliase-Pqpz.

As of Nov 13, 2026, BLA 761079 (Palynziq), held by Biomarin Pharm, was first approved by FDA on May 24, 2018, with 7 approved supplements and 0 published complete response letters.

First approved: May 24, 2018
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 27, 2026	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 6, 2020	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 6, 2020	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 6, 2020	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 24, 2018	Original applicationNew molecular entity · Priority review	Approved	REMS Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Palynziq2.5MG/0.5ML · injectable;injection	Pegvaliase-Pqpz	Rx
Palynziq10MG/0.5ML · injectable;injection	Pegvaliase-Pqpz	Rx
Palynziq20MG/ML · injectable;injection	Pegvaliase-Pqpz	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 27, 2026	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 20, 2025	Supplement 34Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 9, 2023	Supplement 25REMS	Approved	Letter
Nov 20, 2020	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 6, 2020	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 6, 2020	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 6, 2020	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 24, 2018	Original applicationNew molecular entity · Priority review	Approved	REMS Review Letter Label

Identifiers

Application: BLA 761079
Drugs@FDA: Overview at FDA
Company: BioMarin Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters