European Commission

The European Commission has launched an antitrust investigation into SAP, focusing on potential anti-competitive practices within its on-premises software support services. The probe will examine if SAP’s policies unfairly restrict competition in the aftermarket for maintenance and support, potentially limiting options and increasing costs for businesses. SAP believes its policies comply with EU rules and is cooperating with the Commission. The investigation arrives as SAP transitions to cloud-based services and could influence its future business practices. SAP shares dipped following the announcement.

Microsoft has reached an agreement with the EU to unbundle Teams from its Office 365 and Microsoft 365 suites, averting antitrust fines. The move follows a European Commission investigation prompted by a complaint from Slack regarding anti-competitive bundling. Microsoft will offer suites without Teams at a reduced price and facilitate interoperability with rival platforms. The agreement aims to ensure fair market access and prevent hindering competition. Microsoft has increased the price differential and will more prominently advertise suites without Teams. The EU’s decision signals increased scrutiny of tech bundling practices.

Gilead Sciences’ Yeytuo^® (lenacapavir), a twice-yearly injectable HIV-1 capsid inhibitor, has received European Commission (EC) approval for pre-exposure prophylaxis (PrEP). This marks the first and only twice-yearly PrEP option available in the EU, plus Norway, Iceland, and Liechtenstein. Backed by Phase 3 PURPOSE 1 and 2 trial data showing high efficacy, the EC decision follows FDA approval and WHO recommendations. This approval aims to address unmet needs in HIV prevention, particularly among vulnerable populations, and accelerate progress toward ending the HIV epidemic in Europe.

SpringWorks Therapeutics’ EZMEKLY® (mirdametinib) received conditional EU approval for NF1-PN in adults and children (2+), marking the first and only EU-approved therapy for this rare genetic disorder. Backed by Phase 2b ReNeu trial data (n=114), EZMEKLY showed objective response rates of 41% in adults and 52% in pediatric patients, with ~41-42% median tumor volume reduction and durable responses. Available in capsule and dispersible tablet forms, EZMEKLY addresses a significant unmet need in an estimated 135,000 EU patients.

Halozyme Therapeutics announced the European Commission’s approval of argenx’s VYVGART subcutaneous injection, utilizing Halozyme’s ENHANZE drug delivery technology, for chronic inflammatory demyelinating polyneuropathy (CIDP). This approval, based on positive ADHERE trial data, marks a significant advancement for CIDP treatment and expands drug access across Europe. VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, represents a new treatment mechanism in over three decades. The SC injection can be administered by patients, caregivers, or healthcare professionals.