Pharmaceutical Industry Roundup: Vertex's Cystic Fibrosis Drug Approved, Merck Advances HIV Prevention, and Atara Resubmits Cell Therapy Application

In a series of significant developments across the pharmaceutical landscape, several major players have made strides in drug approvals, clinical trials, and regulatory submissions. From expanded access to cystic fibrosis treatments to advancements in HIV prevention, the industry continues to push forward in addressing critical healthcare needs.

Vertex Secures UK Coverage for Cystic Fibrosis Drug Alyftrek

Vertex Pharmaceuticals has achieved a notable victory in the United Kingdom, with the National Health Service (NHS) in England agreeing to cover their newest cystic fibrosis medicine, Alyftrek. This decision follows a rapid review by UK drug cost regulators, who issued a positive draft recommendation. Alyftrek, approved in the country in March, is indicated for use in patients 6 years or older with cystic fibrosis and at least one type of mutation in the CFTR gene.

The NHS secured an unspecified discount on Alyftrek, which carries a list price of 16,110 pounds per 84-tablet pack of one dosage form or 56-tablet pack of another in the UK. The drug's recent authorization in the EU is expected to facilitate access for patients in Ireland, Denmark, and Germany as well, thanks to existing agreements with these nations.

Merck Initiates Phase 3 Trials for Once-Monthly HIV Prevention Pill

Merck & Co. has launched Phase 3 testing of its experimental once-monthly pill for HIV prevention, known as MK-8527. Two pivotal studies are underway:

1. A study testing MK-8527 in individuals with a higher likelihood of HIV-1 exposure across 16 countries, set to begin enrollment in August.
2. A trial in collaboration with the Gates Foundation, evaluating the drug in women and adolescent girls in sub-Saharan Africa, with recruitment expected to commence in the coming months.

This development marks a significant step in the evolution of HIV pre-exposure prophylaxis (PrEP), potentially offering an alternative to daily pills and competing with Gilead Sciences' recently approved twice-yearly injectable medicine.

Atara Biotherapeutics Resubmits FDA Application for Cell Therapy Ebvallo

Atara Biotherapeutics has resubmitted its FDA application for Ebvallo, a cell therapy developed to treat a serious complication associated with transplant surgeries. This resubmission follows a rejection by the agency in January and subsequent suspension of multiple Atara studies due to compliance issues at a third-party manufacturing site.

Since then, Atara has addressed these challenges by transferring all operational responsibilities for Ebvallo, including manufacturing, to Pierre Fabre Laboratories. While Atara remains the sponsor of the FDA application, it stands to receive a milestone payment and sales royalties if Ebvallo gains approval.

This resubmission represents a crucial step in Atara's efforts to bring Ebvallo to market, potentially offering a new treatment option for transplant patients facing serious complications.