Latest FDA Approvals for Biocom California Members

Providing a timely update on the latest drug and device approvals and indications received by Biocom California member companies from the US Food and Drug Administration (FDA).

Abbott Gains FDA Clearance for its FreeStyle Libre 3 System for Diabetes

Abott’s FreeStyle Libre 3 system is the world’s smallest, thinnest glucose sensor, roughly the size of two stacked pennies. It sends updates directly to the user’s smartphone every minute, enabling users to check their glucose in real-time without having to fingerstick. The FDA cleared device allows the millions of adults in the U.S. living with diabetes a discreet and seamless way to achieve improved glycemic control. “The FreeStyle Libre 3 system is a direct result of listening to our customers—and giving them the innovation and sensing technology they’ve been looking for,” Jared Watkin, senior vice president of Abbott’s diabetes care business, said in a statement.

BMS Granted FDA Approval for Opdivo and Yervoy for Esophageal Cancer

Bristol Myers Squibb’s Opdivo, used in combined with the company’s Yervoy or fluoropyrimidine- and platinum-based chemotherapy, has been granted a new indication for treating patients with advanced/metastatic esophageal squamous cell carcinoma (ESCC). In the CheckMate-648 study, the largest for any immunotherapy in ESCC, both regimens were shown to improve overall survival when compared to chemotherapy alone. “Today brings welcome news for many advanced or metastatic oesophageal squamous cell carcinoma patients and oncologists,” said Jaffer Ajani of MD Anderson Cancer Centre, CheckMate-648’s lead US investigator.

BMS Gets New Indication for Vidaza for Juvenile Myelomonocytic Leukemia

The FDA granted a new indication for Vidaza, a chemotherapy drug from Celgene’s old pipeline for treating pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). Findings from an international study of 18 pediatric patients with JMML showed that 9 patients had confirmed clinical responses with 3 having complete clinical remission and 6 with partial remission. Vidaza was originally approved in 2004 for treating acute myeloid leukemia and myelodysplastic syndromes (MDS).

Novartis Receives Approval for Kymriah for Follicular Lymphoma

Novartis received an FDA nod for its CAR-T therapy Kymriah with a new indication for treating relapsed/refractory follicular lymphoma adults who have received two or more lines of systemic therapy. In the phase 2 ELARA trial, 86% of patients who received Kymriah achieved a response, including 68% who saw their cancer completely gone in a complete response. “We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” Victor Bulto, president of Novartis Innovative Medicines U.S., said of Kymriah in a statement.

Lilly’s Mounjaro Gets FDA Nod in Type 2 Diabetes

Eli Lilly’s Mounjaro has been approved for improving blood sugar control in adults with type 2 diabetes, in combination with diet and exercise. Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies. More than 30 million Americans have type 2 diabetes, the most common form of diabetes, and despite the availability of many medications to treat diabetes, many patients do not achieve the recommended blood sugar goals. “We are thrilled to introduce Mounjaro, which represents the first new class of type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the diabetes community,” said Mike Mason, president, Lilly Diabetes.

United Therapeutics Scores FDA Approval for Tyvaso DPI for Pulmonary Hypertension

United Therapeutics’ Tyvaso DPI has been approved in powder form for pulmonary arterial hypertension (PAH). The new delivery method is more convenient, with an inhaler that fits in the palm of the hand and is the only dry powder inhaler approved by the FDA for these indications. Tyvaso, a prostacyclin vasodilator, was originally approved in 2009 to treat PAH and in April of last year, it gained the pulmonary hypertension associated with interstitial lung disease (PH-ILD) indication, enabling United Therapeutics to add 30,000 to 100,000 potential new patients.