Insights+: The US FDA New Drug Approvals in July 2022

The US FDA approved 4 NDAs and 1 BLA in July 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 42 novel products in 2022
In July 2022, the major highlights drugs were Zonisade’s approval for partial seizures in adults and pediatric patients with epilepsy, Opzelura (ruxolitinib) for Vitiligo, Kyzatrex for Hypogonadism
PharmaShots has compiled a list of a total of 5 new drugs approved by the US FDA in July 2022

Zoryve

Active ingredient: roflumilast Approved: July 1, 2022

Company: Arcutis Biotherapeutics Disease: Plaque Psoriasis

The US FDA has approved the NDA for Zoryve (0.3%) for PsO, incl. intertriginous areas in patients aged ≥12yrs. The therapy is expected to be available in mid-August
The therapy has been shown to rapidly clear plaques & reduce itch across all areas of the body & was found to be safe & well tolerated in multiple clinical trials with improvements in disease clearance in hard-to-treat areas
The company has launched a ZORYVE patient support program that provides access to commercially insured patients to use Zoryve & offers the payer process, lowering the out-of-pocket cost for eligible patients. The company offers Arcutis Cares PAP which will give Zoryve to financially qualified patients who are uninsured or underinsured at free cost

Zonisade

Active ingredient: zonisamide Approved: July 18, 2022

Company: Azurity Pharmaceuticals Disease: Epilepsy

The US FDA has approved Zonisade (100mg/5mL) for partial seizures in adults & pediatric patients aged ≥16yrs. with epilepsy who have difficulty in swallowing or are unable to take tablets
In the three trials, the efficacy & tolerability of zonisamide has been evaluated. The first study showed significant treatment differences across 100/200/400mg dose levels while in 2nd & 3rd studies, significant differences across 400mg to 600mg dose with no apparent difference b/w qd & BID
In an additional analysis of the first 4wks. of treatment, significant differences from PBO b/w 100 & 400mg dose. Zonisade marks the first US FDA-approved oral liquid formulation of zonisamide that helps to reduce the burden & improve treatment adherence

Opzelura

Active ingredient: ruxolitinib Approved: July 19, 2022

Company: Incyte Disease: Vitiligo

The approval was based on the P-III (TRuE-V1 & V2) trial evaluating the safety and efficacy of Opzelura vs vehicle in 600+ patients aged ≥12yrs. with nonsegmental vitiligo
The results showed a significant improvement in VASI scores representing improvements in facial and total body repigmentation @24 & 52wk. The results were consistent across both studies @24wk., ~30% vs 8% and 13% in (TRuE-V1 & V2) trial & ≥15% vs 2% of patients achieved ≥75% & ≥90% improvement from baseline in F-VASI75 & F-VASI90 @24wk.; ~50% & ~30% @52wk.
The company also launched a patient support program i.e., IncyteCARES that provide access to eligible patients to use Opzelura & also offers financial assistance, ongoing education, and resources

Benlysta

Active ingredient: belimumab Approved: July 27, 2022

Company: GSK Disease: Active Lupus Nephritis

The US FDA has approved Benlysta (BLyS-specific inhibitor) for the treatment of active LN who received standard therapy in children aged 5 to 17yrs.
The main objective of treating lupus nephritis in both adults and children is to maintain renal function while reducing side effects from treatment and associated morbidity
Benlysta is a human mAb that binds to soluble BLyS. The therapy has the potential to suppress B cell survival incl. autoreactive B cells and slows down the development of B cells into immunoglobulin-producing plasma cells by binding to BLyS

Kyzatrex

Active ingredient: testosterone undecanoate Approved: July 31, 2022

Company: Marius Pharmaceuticals Disease: Hypogonadism

The US FDA has approved Kyzatrex, an oral testosterone replacement therapy in adult males with hypogonadism. The product is supplied as 100/150/200mg
The approval was based on the P-III (MRS-TU-2019EXT) study that evaluated Kyzatrex in 155 hypogonadal males aged b/w 18 & 65yrs. which showed that 88% of patients achieved a 24hr. mean plasma total testosterone concentration within the normal range of 222-800ng/dL on the final PK visit @90 day & had a maximum total testosterone concentration threshold ≤1200ng/dL b/w 1400 & 2000ng/dL, & ≥2000ng/dL at the final PK visit were 88%, 4% & 0%, respectively
In exploratory EPs, improvements in QoL, energy/fatigue, erectile function, intercourse satisfaction, and positive mood were observed