FDA Updates: An Interchangeable Biosimilar for Insulin Leads the Week


Approval of the first interchangeable biosimilar; new indications for Keytruda, Botox, and Nucala; Shingrix label's expanded to a new patient population; and Ardelyx’s Complete Response Letter round out this week's FDA news.

FDA approves first interchangeable biosimilar

The FDA has approved the first interchangeable biosimilar.

Developed by Mylan Pharmaceuticals, now Viatris, in partnership with Biocon Biologics, Semglee (insulin glargine-yfgn) is interchangeable with its reference product, Sanofi’s Lantus (insulin glargine), a long-acting insulin analog used to improve the control of blood sugar levels in people with diabetes. Semglee is the first interchangeable biosimilar product approved in the United States. The interchangeable designation means a pharmacy can use Semglee to fill a prescription for insulin glargine, although state-level pharmacy laws apply and may put some limitations on the substitution.

Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily. It is not recommended for treating diabetic ketoacidosis. In a statement, Viatris officials said commercial preparations for launch are under way.

Keytruda nabs another indication

The FDA has approved Keytruda (pembrolizumab), Merck’s checkpoint inhibitor therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy before surgery and then continued as a single agent after surgery. The approval is based on the phase 3 KEYNOTE-522 trial, which found that Keytruda resulted in a 37% reduction in the risk of disease progression, a local/distant recurrence, a second primary cancer, or death from any cause.

Additionally, the FDA converted the accelerated approval of Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 to a full approval based on confirmatory data from KEYNOTE-522. This approval was originally granted in November 2020 based on results from the phase 3 KEYNOTE-355 trial.

Keytruda was first approved as a treatment for melanoma in 2014. It is now approved as a treatment for over a dozen different types of cancers.

FDA approves expanded label for Shingrix in new patient population

GlaxoSmithKline has announced the FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) to prevent shingles in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by disease or therapy. Shingrix, which is administered intramuscularly in two doses, was initially approved in 2017 for the prevention of shingles in adults 50 years of age or older.

GSK’s Nucala approved for new indication

The FDA has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. This is the first anti-IL-5 approved for this indication in the United States.

Nucala is approved for three other eosinophilic-driven diseases. It's first indication was as a treatment for patients with severe eosinophilic asthma aged six years and older. It was also first approved biologic therapy for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and the first approved biologic for patients aged 12 years and older with hypereosinophilic syndrome.

IV form of Uptravi receives approval for PAH

Janssen Pharmaceuticals has received FDA approval for its IV formulation of Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension. The new IV formulation is approved for adult patients who are temporarily unable to take oral therapy. The approval is based on a prospective, multicenter, open-label crossover phase 3 study designed to assess the safety, tolerability, and pharmacokinetics of temporarily switching between the tablet and the IV formulations. Uptravi tablets were approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for pulmonary arterial hypertension.

FDA approves new acne medication

Sol-Gel Technologies, an Israeli company, has announced that the FDA has approved its first product, Twyneo, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. The therapy uses Sol-Gel’s patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients to provide a favorable efficacy and safety profile. Sol-Gel has partnered with Galderma, a Swiss company, to commercialize Twyneo TWYNEO in the United States.

Botox label gets expanded label

Allergan, an AbbVie, company, has announced that the FDA has approved a label expansion of Botox (botulinum toxin) to include eight new muscles for the treatment of upper limb spasticity in adults. These include muscles of the elbow and forearm as well as intrinsic hand muscles and thumb muscles.

Botox was first approved by the FDA in 1989 for two rare eye muscle disorders, blepharospasm and strabismus. Today Botox is FDA-approved for 12 therapeutic indications, including chronic migraine, overactive bladder, incontinence due to overactive bladder caused by a neurologic condition in adults, cervical dystonia, adult and pediatric spasticity, severe underarm sweating, and pediatric detrusor overactivity associated with a neurologic condition.

Olumiant now has EUA as monotherapy for COVID-19

The FDA has revised the emergency use authorization (EUA) for Eli Lilly’s Olumiant (baricitinib) so that it can be now used alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The change in the EUA is based on the phase 3 COV-BARRIER study, which found that although Olumiant reduced the risk of mortality above the recommended standard of care, without additional safety risks, although it did not meet the primary endpoint based on stages of disease progression,

The initial EUA was based on data from the adaptive COVID-19 Treatment Trial (ACTT-2), a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Olumiant in combination with Veklury (remdesivir) versus placebo with in hospitalized patients with or without oxygen requirements.

Olumiant has full FDA approval as a treatment for rheumatoid arthritis in adults.

FDA expands EUA for Regeneron's COVID-19 cocktail

The FDA has updated the emergency use authorization (EUA) for Regeneron's COVID-19 antibody cocktail, Regen-COV (casirivimab and imdevimab). The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, or who are at high risk of exposure occurring in an institutional setting.

Under the EUA for post-exposure prophylaxis, Regen-COV can be administered by subcutaneous injection or intravenous infusion. The initial 1,200-mg dose can be followed by repeat dosing of 600 mg once every four weeks.

Ardelyx receives Complete Response Letter for kidney disease therapy

Ardelyx has received a complete response letter (CRL) from the FDA for its application for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. A complete response letter from the FDA lists the shortcomings the agency's reviewers found in an application for approval. Regulators noted that data submitted show the treatment effect is small and of unclear clinical significance.

Additionally, the FDA noted that for the application to be approved, Ardelyx needs to conduct an additional well-controlled trial demonstrating clinical relevance on its effect on serum phosphorus. There were no safety, clinical pharmacology/biopharmaceutics, CMC or nonclinical issues identified in the CRL.

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