Tadliq Receives FDA Approval

Tadliq® (tadalafil – CMP Pharma) 4mg/mL oral suspension, approved by the FDA on June 17, 2022, is now available through specialty pharmacies, including Accredo. The first commercially available oral liquid formulation of the phosphodiesterase 5 (PDE5) inhibitor, tadalafil, is indicated for patients who need treatment for pulmonary arterial hypertension (PAH), but who cannot swallow tablets easily. The recommended dose is 40mg (10mL) once a day. It should not be used by patients who also take any other PDE5 inhibitor; an organic nitrate, such as nitroglycerin; or a guanylate cyclase stimulator, such as Adempas^® (riociguat). According to Good Rx, one 150mL bottle of Tadliq retails for about $2,000. Prescribing information is here.

FDA Grants New Indication for Rinvoq

On Oct. 21, 2022, Rinvoq^® (upadacitinib – AbbVie) extended-release tablets were FDA-approved to treat active non-radiographic axial spondyloarthritis (nr-axSpA) for adults who cannot use a tumor necrosis factor (TNF) blocker. The Spondylitis Association of America estimates that about 2.7 million Americans haveaxial spondyloarthritis (axSpA), an inflammatory arthritis of the spine that usually is diagnosed in the late teens to mid-forties for patients who have chronic, severe back pain. Up to 35% of those patients have nr-axSpA, which is hard to diagnose because x-rays do not show it. All forms of axSpA are painful and progressive. Ultimately, the spine can become twisted and/or fused. Rinvoq helps to decrease inflammation by blocking the Janus-associated kinase (JAK) pathways that relay inflammatory signals inside cells. To treat nr-axSpA, the recommended dose of Rinvoq is 15mg once a day. Originally approved by the FDA in 2019 to treat rheumatoid arthritis (RA), it later was given additional indications, including second-line treatment for adults who have ankylosing spondylitis (AS), psoriatic arthritis (PsA) or ulcerative colitis (UC). It also is indicated to treat atopic dermatitis for patients aged 12 years old and older who weigh at least 40kg (88 pounds). A boxed warning outlines the increased risks of blood clots, cancer, cardiovascular events, and serious infections that may be associated with the use of any JAK inhibitor, including Rinvoq. Patients taking one of them also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. A tumor necrosis factor (TNF) blocker, Cimzia^® (certolizumab pegol) injection, and two interleukin-17 (IL-17) inhibitors, Cosentyx^® (secukinumab) injection and Taltz^® (ixekizumab) injection, also are FDA approved to treat nr-axSpA. Check here for Rinvoq’s updated prescribing information.

FDA Approves Lyumjev to Treat Children

Eli Lilly’s Lyumjev^® (insulin lispro-aabc) U-100 and U-200 received approval from the FDA on Oct. 14, 2022, to improve the management of blood sugar for children and teens who have type 1 diabetes. An ultra-rapid-acting insulin, Lyumjev can be injected subcutaneously (SC) immediately before meals or within 20 minutes of beginning a meal. Ordinarily, longer-acting insulin is used, as well. In a six-month long, phase III clinical study that included children as young as one year old, the effectiveness of Lyumjev was comparable to Humalog® (insulin lispro [rDNA origin]). Lyumjev is available in 10mL vials, prefilled KwikPens®, and Junior KwikPens^®, which can deliver smaller doses. It also is approved for continuous infusion through a compatible insulin pump and for adults who have either type 1 or type 2 diabetes. Here is the revised prescribing information for Lyumjev.

First Generic Launched for Cetrotide

Akorn Operating Company announced on Oct. 27, 2022, that it has launched cetrorelix 0.25mg powder for injection, the first AP-rated generic for EMD Serono’s Cetrotide^®. Injected SC, is approved to inhibit premature surges of luteinizing hormone (LH) for women undergoing controlled ovarian stimulation during an assisted reproductive technology (ART) procedure. Usually, it is self-administered once a day on specified days of each treatment cycle. As the first approved generic and under the FDA Competitive Generic Therapy (CGT) designation, Akorn has 180-day exclusivity before another generic can enter the U.S. market. IQVIA estimates that U.S. annual sales for the branded product will reach about $127 million in 2022.

Recalls
Susvimo

The currently unused supply of reservoirs and insertion devices for Susvimo^™ (ranibizumab – Genentech/Roche) ocular implant systems have been recalled. Indicated to treat neovascular age-related macular degeneration (nAMD), the systems include tiny permanent reservoirs that are implanted surgically into the eye. Filled with 100mg of medication – enough to last approximately six months – the reservoirs can be refilled indefinitely. However, the sealing membranes of some reservoirs have begun to leak following repeated punctures under testing conditions. While the implants are re-engineered, which is expected to take about one year, no new reservoirs will be inserted for patients. Those who already have implanted Susvimo reservoirs do not need to have them removed; refills still can be injected as usual. No safety or effectiveness concerns have been raised about the medication, itself. More information is in Genentech’s notice.

Octreotide
Mylan Institutional recalled one lot of prefilled octreotide syringes on Oct. 25, 2022, because glass particles were reported in one syringe from the lot. The risk is small, but, if injected, particulates could cause injection site irritation, vasculitis or microvascular blockage. Typically used in hospitals, octreotide is given to treat acromegaly and to relieve severe diarrhea associated with some carcinoid tumors. The FDA notice about the recall is here.