Theratechnologies Inc., a leading biopharmaceutical company based in Montreal, has announced a potentially significant disruption in the supply of its body fat reduction medication, EGRIFTA SV, expected in early 2025. The looming shortage follows a voluntary shutdown of the company’s contract manufacturer’s facility in response to an inspection by the U.S. Food and Drug Administration (FDA). This halt in production could severely impact the availability of EGRIFTA SV, a vital drug used in the treatment of excess abdominal fat in HIV patients.

Theratechnologies Prepares for Supply Chain Fallout

Theratechnologies has disclosed that the FDA’s observations were not directly linked to the production of EGRIFTA SV itself but rather to the overall manufacturing environment at the facility. The company has been collaborating closely with its contract manufacturer and the FDA to expedite the resumption of production. The manufacturer is expected to restart operations by mid-October 2024, with a new batch of EGRIFTA SV scheduled for production on October 21, 2024. However, the company must submit a Prior Approval Supplement (PAS) to the FDA, detailing the changes implemented at the facility. This process, typically taking four months, could delay the availability of new supplies into 2025.

Paul Lévesque, President and CEO of Theratechnologies, has indicated that the company is proactively managing its inventory to avoid immediate impact on patients. However, he also highlighted that despite these efforts, a shortfall in revenue of approximately $1.6 million is expected for the fiscal year 2024 due to the anticipated supply shortage.

EGRIFTA SV’s Critical Role in HIV Treatment

EGRIFTA SV is the only FDA-approved treatment for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. As a growth hormone-releasing factor (GHRF) analog, EGRIFTA SV stimulates the production and release of endogenous growth hormone, which aids in reducing abdominal fat. The shutdown of its production facility presents a significant risk to HIV patients who depend on this medication for managing their condition. The biopharmaceutical industry and healthcare providers are watching closely to see how Theratechnologies manages this disruption and communicates with stakeholders to prevent any potential health crises.

A Closer Look at the FDA’s Role and Future Outlook

The FDA’s involvement has been central to this situation. Following an inspection earlier in 2024, the regulatory body cited several concerns about the manufacturing environment, though it cleared the actual production processes for EGRIFTA SV. As a result, the manufacturer opted for a voluntary shutdown to address these concerns comprehensively. To resume the supply chain, Theratechnologies must await the FDA’s review of the PAS, adding another layer of complexity to the drug’s availability timeline.

This is not the first time Theratechnologies has faced regulatory hurdles. Earlier in 2024, the FDA issued a Complete Response Letter (CRL) regarding the F8 formulation of tesamorelin, a newer version of the drug. While this CRL does not impact the current EGRIFTA SV formulation, it adds to the regulatory challenges faced by the company. Theratechnologies has since announced plans to address the FDA’s concerns about the F8 formulation to bring it to market as part of their strategy to offer innovative treatments for people with HIV.

Expert Analysis: Navigating Regulatory and Operational Hurdles

The challenges faced by Theratechnologies are not unique but are certainly critical in the context of regulatory compliance and patient impact. According to industry experts, the company’s response to these challenges will be pivotal in determining its future in the biopharmaceutical sector. The emphasis on close collaboration with the FDA and proactive inventory management are positive steps. Still, the potential for revenue shortfalls and the dependency on regulatory timelines suggest that Theratechnologies must consider alternative strategies to mitigate risks. Diversifying its product portfolio and exploring new markets could be essential for long-term stability.

What Lies Ahead for Theratechnologies

As the company braces for potential disruptions in the supply of EGRIFTA SV, stakeholders, including investors, healthcare providers, and patients, are closely monitoring how Theratechnologies navigates this crisis. The resolution of the manufacturing shutdown and the successful review of the PAS will be critical milestones. The situation underscores the importance of regulatory compliance, robust supply chain management, and strategic agility in the highly regulated biopharmaceutical industry.

  EGRIFTA SV, FDA, Montreal, Paul Lévesque, tesamorelin, Theratechnologies, U.S. Food and Drug Administration