Pharmaceutical Market Europe • September 2026 • 8
NEWS
Pfizer and Valneva’s Lyme disease vaccine candidate application validated
Pfizer and Valneva’s Marketing Authorisation Application (MAA) for their Lyme disease vaccine candidate has been validated by the European Medicines Agency (EMA). The application is based on the phase 3 VALOR clinical trial, based in areas of high incidence of Lyme disease across the US, Canada and Europe and included 9,437 trial participants aged five years and older.
Lyme disease is a systemic infection caused by bacteria that are transmitted to humans by the bite of infected Ixodes ticks. It is considered the most common vector-borne illness in the northern hemisphere.
Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other non-specific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system.
The Centers for Disease Control and Prevention (CDC) estimates around 476,000 people in the US are diagnosed and treated each year, with 132,000 cases reported annually in Europe.
LEO Pharma acquires rights for dersimelagon from Tanabe Pharma
LEO Pharma has agreed to acquire worldwide rights to dersimelagon from Tanabe Pharma. Dersimelagon is an oral, once-daily small MC1R agonist being developed for EPP and XLP.
EPP and XLP are rare and severe genetic diseases that cause severe sunlight-induced skin damage and can significantly limit patients’ ability to spend time outdoors. Symptoms may include skin rash, swelling, redness, burning sensations and, in some cases, liver damage. Dersimelagon is designed to increase skin melanin, helping reduce sunlight penetration and protect against phototoxic reactions.
If approved, dersimelagon would represent the first oral therapy for the treatment of EPP and XLP and help address an area of significant unmet need.
Under the terms of the agreement, LEO Pharma will acquire worldwide rights to dersimelagon from Tanabe Pharma for up to $435m in upfront and near-term milestone payments together with potential down- stream milestones and tiered royalties on net sales.
Dersimelagon has been granted both US FDA Fast Track Designation and Orphan Drug Designation, and an NDA for the treatment of EPP and XLP was submitted to the US FDA for regulatory review in June 2026.
Roche’s Enspryng gets Priority Review for autoimmune disease
Roche’s Enspryng (satralizumab), a treatment for a rare autoimmune disease, has been given FDA Priority Review to a supplemental Biologics License Application (sBLA). The FDA is expected to make a decision on approval in MOGAD by 10 January 2027.
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a rare autoimmune disease where the immune system mistakenly attacks parts of the central nervous system. It can cause sudden attacks on the optic nerves, brain and spinal cord, which can lead to vision loss, confusion, muscle weakness and disability.
MOGAD is estimated to impact 0.51 to 3.42 per 100,000 people, affecting all ages, with the symptoms that are often severe and debilitating. Relapsing MOGAD is characterised by multiple, unpredictable attacks of worsening neurological symptoms. Symptoms may not fully resolve after an attack, leading to accumulating, permanent, neurological damage, vision loss and disability.
The European Medicines Agency (EMA) has validated the application for Enspryng for MOGAD in Europe. The decision by the European Commission is expected in the third quarter of 2027. Currently, there are no approved treatment options available for MOGAD.