Xeris’ Recorlev Now Available in US From PANTHERx Rare Pharmacy

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by Vanda Pinto, PhD |

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Xeris Biopharma’s newly approved therapy Recorlev (levoketoconazole) is now available to patients in the U.S. through the specialty pharmacy PANTHERx Rare, the company announced in a press release. The therapy is prescribed for adults with endogenous Cushing’s syndrome for whom surgery is not possible or not effective.

“The commercial availability of Recorlev represents a significant milestone for the Cushing’s syndrome community, particularly for people living with uncontrolled disease, who until now were faced with limited therapeutic options,” said Paul Edick, Xeris Biopharma’s chairman and CEO.

To make it easier to access Recorlev, the company has created a support program called Xeris CareConnection, which offers patients personalized assistance, educational resources, and financial aid. There is a $0 co-pay for commercially insured patients, the company noted.

Through the program, patients may receive welcome information, therapy on-boarding, and home delivery of medication. Patients also can arrange a courier service for urinary free cortisol (UFC) test collection and automatic monthly refill shipments.

Xeris CareConnection also supports healthcare professionals by providing information on access and reimbursements.

“Xeris is proud to introduce this meaningful new treatment option to patients in the U.S. and is focused on meeting the needs of the rare disease community by ensuring access to treatment and providing comprehensive patient and physician support services,” Edick said.

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FDA Approves Recorlev for Adults With Endogenous Cushing’s

Endogenous Cushing’s syndrome is characterized by the excessive production of the stress hormone cortisol, typically due to the presence of a tumor. Too much cortisol in the body can cause weight gain, hypertension (high blood pressure), and high cholesterol and sugar levels in the blood, which may lead to heart problems.

When the cause of Cushing’s syndrome is a tumor, complete surgical removal is often recommended. However, for some people, surgery may not be a viable option, or sometimes symptoms may persist despite the procedure. Recorlev was developed to help manage disease-related symptoms and suppress cortisol production in these patients.

The medication was recently approved by the U.S. Food and Drug Administration based on positive safety and efficacy data from two Phase 3 trials: SONICS (NCT01838551) and LOGICS (NCT032776909).

Collectively, the two studies enrolled 166 participants with Cushing’s. Findings showed that treatment with Recorlev for six months was safe and could lower urinary cortisol levels to a normal range in about 30% of participants. Improvements in quality life and symptom relief also were reported.

Further data also revealed that Recorlev may help control diabetes, as well as lower cholesterol levels and body fat.

The approval also was supported by data from an ongoing open-label study, called OPTICS (NCT03621280), which will continue to evaluate the safety and effectiveness of Recorlev for up to three years.

“Normalization of cortisol levels is the first and most important clinical objective in the treatment of Cushing’s syndrome and the approval of new medicines like Recorlev can aid physicians and patients to achieve this objective,” said Ken Johnson, senior vice president of global development and medical affairs at Xeris.

“Many of the symptoms of [Cushing’s syndrome] can significantly impact self-esteem, body image, and intimate relationships, therefore, it is exciting to now be able to offer patients suffering from this condition an effective oral treatment option,” Johnson added.