Daiichi Sankyo's major cardiovascular drugs hit by supply shortages

해외 제조소 정비 여파…한 달여 물량 부족

Production and shipment delays at overseas manufacturing site… leaves market short for over a month

Supply shortages of Daiichi Sankyo Korea’s major cardiovascular drugs are placing increasing pressure on medical sites.

Production and shipment schedules have been delayed due to maintenance work at the company’s overseas manufacturing facility, resulting in simultaneous supply disruptions for the anticoagulant ‘Lixiana (edoxaban),’ the triple-combination antihypertensive ‘Sevikar HCT (olmesartan/amlodipine/hydrochlorothiazide),’ and the antiplatelet agent Efient (prasugrel).

Although severity varies by product and strength, supplies of some products have deteriorated to the point that inventories are scarce across distribution channels. Hospitals, clinics, and pharmacies have reportedly been checking remaining stock or considering alternative therapies in an effort to maintain existing prescriptions.

According to industry sources on July 28, supply shortages of Lixiana, Sevikar HCT, and Efient have persisted since last month.

(Clockwise from the left) Lixiana, Sevikar HCT, and Efient

Daiichi Sankyo Korea attributed the disruption to maintenance work at its manufacturing facility in Germany, which delayed production and shipments. The manufacturing issue is understood to be affecting product supplies not only in Korea but also across global markets.

A Daiichi Sankyo Korea official said, "The products are not completely out of stock, but we have been unable to distribute enough inventory to meet market demand. However, we assess that the supply issues are gradually easing."

Lixiana is currently experiencing the most severe supply shortage. Inventories of Lixiana 15mg and 30mg have virtually been depleted, and it is understood that even 60mg, which had relatively remaining stock, is left with almost no supply capacity.

Some healthcare institutions are receiving limited quantities that can only meet individual patient prescriptions. Even major wholesalers and the distribution network of Daewoong Pharmaceutical, which co-promotes the product, have been unable to secure sufficient inventories, making it difficult to fulfill orders from medical institutions.

Lixiana is a direct oral anticoagulant (DOAC) indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and to treat deep vein thrombosis and pulmonary embolism. Because anticoagulants are often taken continuously over the long term, supply interruptions may force physicians to switch patients to alternative products within the same class.

Sevikar HCT and Efient are also experiencing varying degrees of shortages depending on the strength, but overall, supplies remain insufficient to fully meet demand.

Sevikar HCT is an olmesartan-based triple-combination antihypertensive, while Efient is an antiplatelet therapy used to prevent thrombotic cardiovascular events in patients with acute coronary syndrome.

Because all three products are maintenance therapies for patients with cardiovascular disease, prolonged supply disruptions could further increase the burden on-site. Even when alternative products or therapies are available, treatment changes must be made carefully based on each patient's clinical condition and response to previous therapy.

A distribution industry official said, "Lixiana 15 mg and 30 mg are virtually impossible to obtain, and inventories of the 60 mg strength are also running very low. Even when hospitals place orders, they are often supplied with only part of the requested quantity or with only the minimum amount needed for individual patients."

The official added, "Neither wholesalers nor the co-promotion partner have sufficient inventories, suggesting that this is not a problem at a particular distribution stage but rather an overall product supply shortage. The disruption has continued for more than a month, and uncertainty over when supplies will normalize is increasing anxiety in the field."

Some speculate the shift in business strategy had an effect… industry eyes timing of supply normalization

The situation has also prompted speculation that, beyond temporary production issues, changes in Daiichi Sankyo's business priorities may have contributed to the shortage.

As competition in the Lixiana market is set to intensify with generic versions of Lixiana expected to enter Korea's National Health Insurance reimbursement system in the second half of the year, Daiichi Sankyo has been focusing its investments on oncology, particularly antibody-drug conjugates (ADCs).

The company has been expanding its global oncology business around ‘Enhertu (trastuzumab deruxtecan)’ and ‘Datroway (datopotamab deruxtecan)’ while also accelerating the development and commercialization of follow-on ADCs. As a result, some have questioned whether production and supply of cardiovascular products approaching patent expiry have become a lower priority than in the past.

However, as this supply delay is known to have occurred simultaneously in the global market rather than being limited to South Korea, the prevailing view is that it is difficult to interpret it as being directly linked to patent expirations or domestic sales strategies. There is little evidence to suggest the company intentionally reduced supplies to the Korean market because of patent expiration or domestic commercial strategy.

The key question now is when supplies will return to normal. If the disruption continues, it could increase the burden of switching prescriptions for hospitals and pharmacies while also causing inconvenience for patients who have been taking these therapies over the long term.

Daiichi Sankyo Korea is reportedly coordinating the timing for resuming domestic supply based on the completion of maintenance work at the manufacturing facility and product-specific shipment schedules.