Takeda's Approval And Other News: The Good, Bad And Ugly Of Biopharma



Takeda Receives FDA Approval for Brigatinib

Takeda Pharmaceutical Company Limited (TAK) announced that the FDA has given a green signal for its ALUNBRIG (Brigatinib) in adult patients suffering from anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer. The label expansion allows the drug to be used in first line setting.

The FDA approval is based on the data obtained from Phase 3 ALTA 1L trial, which aimed to assess the safety and efficacy of ALUNBRIG compared to crizotinib in adult patients. The participants had ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. Teresa Bitetti, President, Global Oncology Business Unit, Takeda said, “Through a robust clinical development program and ongoing investigations across the NSCLC treatment landscape, Takeda is committed to uncovering solutions for people living with devastating forms of lung cancer in need of new options.”

The trial was succeeded by more than two years of follow up. The data thus obtained showed that the drug candidate had superior performance over crizotinib and offered significant anti-tumor activity, especially in patients suffering from baseline brain metastases. ALUNBRIG decreased the risk of disease progression or death twofold in comparison to crizotinib. The median progression free survival is 24 months compared to 11 months for crizotinib. The confirmed Overall Response Rate stood at 74 percent for the drug candidate while for crizotinib, it was 62 percent. Confirmed intracranial ORR was reported at 78 percent and 26 percent, respectively.

The Phase 3 ALTA 1L trial is a global, randomized, comparative study. This multicenter trial enrolled 275 patients, with 137 being given the drug candidate and remaining were administered crizotinib. These patients had ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. They were given either ALUNBRIG, 180 mg orally once a day with seven-day lead-in at 90 mg once daily, or crizotinib, 250 mg orally two times a day.

The main efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent review committee. Additional efficacy outcomes were confirmed overall response rate (ORR) per RECIST v1.1 and intracranial ORR. The median age of the patients were 58 years and 60 years for the drug candidate and control arms respectively. Brain metastases at baseline stat was 29 percent and 30 percent respectively while the proportion of patients who received prior chemotherapy for advanced or metastatic disease was 26 percent and 27 percent, respectively.

33 percent of the patients who were given the drug candidate showed serious adverse reaction, the major ones being pneumonia, ILD/pneumonitis, pyrexia and dyspnea, among others. The most common adverse reactions were diarrhea, rash, cough, hypertension, and fatigue.

ALUNBRIG is a selective next-generation tyrosine kinase inhibitor and works by targeting anaplastic lymphoma kinase (ALK) molecular alterations. The drug candidate is already approved in several countries globally for treating patients suffering from ALK+ metastatic NSCLC who have taken the medicine crizotinib. The drug candidate is also approved in the European Union as a monotherapy for treating adult patients with ALK+ advanced NSCLC previously not treated with an ALK inhibitor.

The drug candidate was granted Breakthrough Therapy Designation and Orphan Drug Designation by the FDA. The former designation is for treating patients with ALK+ NSCLC whose tumors are resistant to crizotinib while the latter is for treating ALK+ NSCLC, ROS1+ and EGFR+ NSCLC.

FDA Accepts Zealand NDA for HypoPal Rescue Pen

Zealand Pharma (ZEAL) reported that the FDA has accepted its New Drug Application for the dasiglucagon HypoPal® Rescue Pen. The instrument is designed for treating hypoglycemia in people with diabetes. The target action date under the Prescription Drug User Fee Act is March 27, 2021. The FDA has also suggested that it is currently not planning on conducted any advisory committee for discussing the application.

Dasiglucagon HypoPal rescue pen is a ready to use device and is designed to provide quick and effective treatment for severe hypoglycemia to diabetes patients. Adam Steensberg, Executive Vice President, Research and Development, and Chief Medical Officer at Zealand Pharma said, “We are pleased by the FDA’s acceptance of the NDA for the dasiglucagon HypoPal® rescue pen, several weeks ahead of the anticipated response date. It marks an important step toward bringing a potential treatment option to people with diabetes at risk of severe hypoglycemia.” Subject to the FDA approval, the company expects the pen to be launched in the market in early 2021.

For its pivotal and confirmatory Phase 3 trials, HypoPal met all the primary and secondary endpoints. It reported the median time for blood glucose recovery at 10 minutes. The data from its pediatric Phase 3 study showed the same blood glucose recovery time of 10 minutes. These results were presented in September 2019. The company is collaborating with Beta Bionics for developing Dasiglucagon dual-hormone artificial pancreas for automated diabetes management.

Zealand Pharma is a biotechnology firm and is mainly involved in developing next generation peptide based medicines for treating various metabolic and gastrointestinal diseases. The company has a strong development pipeline including one candidate under regulatory approval process in the United States and three candidates in late stage development.

Evofem Receives Regulatory Approval for Phexxi Contraceptive

Evofem Biosciences (EVFM) reported that the FDA has given its approval to Phexxi Vaginal Gel 1.8%/1%/0.4%. The gel is a contraceptive and works by creating an acidic environment which is not conducive for sperm. Originally, the company had received a Complete Response Letter for its submission, but it refiled the application in December 2019.

Phexxi is the first on demand, non hormonal contraceptive which maintains vaginal pH within the normal range of 3.5 to 4.5. This spectrum is acidic in nature and thus is inhospitable to sperm. Saundra Pelletier, Evofem Biosciences' Chief Executive Officer said, “The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used ONLY when they need it.” The company is looking to get the treatment to be covered under the Affordable Care Act.

Evofem is aiming to launch the product in early September in conjunction with its Phexxi Concierge Experience, which is a telemedicine support system. It will allow women to get a prescription, check their insurance options and receive counseling. They will also be able to fill their prescription using their local pharmacy or an online pharmacy.

Evofem is a clinical stage company and focuses on developing products related to female reproductive and sexual health. The company’s lead product candidate is Amphora which is being tested for a wide range of indications such as prevention of pregnancy and sexually transmitted diseases including chlamydia and gonorrhea in women.

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