Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates

The FDA worked overtime in October, deciding on the fate of several therapies and treatment options. Most reviews produced positive outcomes.

Three new molecular entities, or NMEs, were approved in October, taking the total number of NME approvals for the year to 33 compared to 47 approvals by the same time last year.

Some notable approvals that came through in the month included Eli Lilly And Co LLY's migraine drug Reyvow and Vertex Pharmaceuticals Incorporated VRTX's new cystic fibrosis triplet regimen Trikafta in patients with a specific mutation.

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Here are the key PDUFA Dates for the upcoming month.

Redhill Awaits Nod For Drug To Treat Carcinogenic Bacterial Infection

• Company: REDHILL BIOPHAR/S ADR RDHL
• Type of Application: NDA
• Candidate: Talicia, or RHB-105
• Indication: H. Pylori infection
• Date: Nov. 2

The NDA was accepted for review on July 3, with a priority review status. H. pylori bacterial infection, according to the company, affects more than 50% of the population worldwide and about 35% of the U.S. population. It's the strongest risk factor for the development of gastric cancer and peptic ulcer disease.

Can Third Time Be Charm For Lipocine's Therapy For Male Sex Hormone Deficiency?

• Company: Lipocine Inc LPCN
• Type of Application: NDA
• Candidate: Tlando, or LPCN 1021
• Indication: testosterone replacement therapy, or TRT, in adult males with hypogonadism
• Date: Nov. 9

Hypogonadism refers to conditions associated with a deficiency of endogenous testosterone. Tlando is designed as a fixed dose oral TRT, which has benefit over topicals due to the absence of risk of accidental testosterone transference.

Incidentally, Lipocine was handed down complete response letter, or CRL, twice earlier, the first time in June 2016 and the second time in May 2018.

The latest CRL cited four deficiencies: determining the extent of ex vivo conversion of testosterone undecanoate to testosterone, obtaining evidence whether Tlando causes a clinically meaningful increase in blood pressure in hypogonadal men, verification of the reliability of Cmax data and determination of stopping criteria.

Following a resubmission that was deemed as complete in May, the regulatory body set the Nov. 9 PDUFA action date.

Allergan Hopes For No Headaches For Migraine Drug

• Company: Allergan plc AGN
• Type of Application: NDA
• Candidate: Ubrogepant
• Indication: Migraine
• Date: Fourth quarter, likely by Nov. 11, given the 10-month standard review period and assuming a submission timeframe of Jan. 11 (60 days prior to the acceptance of the filing)

Allergan said the FDA accepted the NDA for Ubrogepant in March. Ubrogepant is being evaluated for the acute treatment of migraine in adults. The company had filed the NDA, based on two pivotal studies – ACHIEVE I and ACHIEVE II.

Agile Seeks Approval For Birth Control Patch

• Company: Agile Therapeutics Inc AGRX
• Type of Application: NDA
• Candidate: Twirla
• Indication: low-dose combined hormonal contraceptive patch
• Date: Nov. 16

Agile stumbled at the FDA altar twice with respect to its Twirla. The recent rejection was in December 2017, which cited deficiencies related to the manufacturing process and facility and due to questions on the in vivo adhesion properties of Twirla and their potential relationship to the Phase 3 clinical trial results.

The company resubmitted the NDA in May.

FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, which discussed the NDA for Twirla, voted 14 to 1 that the benefits of Twirls outweighs the risks to support approval. One committee member abstained from voting.

Aquestive's Neurodegenerative Disorder Drug Awaits Clearance

• Company: Aquestive Therapeutics Inc AQST
• Type of Application: NDA
• Candidate: Exservan, or riluzole oral film
• Indication: An adjunctive therapy in the treatment of amyotrophic lateral sclerosis, or ALS
• Date: Nov. 30

Adcom Meeting

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Nov. 14 to discuss Amarin Corporation plc AMRN's sNDA for Vascepa for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels and other risk factors for cardiovascular disease.